Opioid Use Disorder
Conditions
Keywords
extended-release naltrexone (Vivitrol), buprenorphine-naloxone (Suboxone), comparative effective, relapse prevention
Brief summary
CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery. The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid). The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient).), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.
Detailed description
For opioid-dependent patients in the U.S. and most of the rest of the world, detoxification or detoxification followed by short term residential treatment, with the goal of achieving long-term abstinence from opioid misuse is a mainstay of treatment. Nonetheless, the majority of patients treated in this way will relapse to opioid misuse, leading to a costly and ineffectual cycle of readmission for repeated detoxifications. The overarching goal of CTN-0051 is to foster adoption of new relapse-prevention pharmacotherapies in community-based treatment programs (CTPs) where these could have a substantial public health impact. To this end CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery. The study is conducted in 8 CTN-affiliated CTPs that provide or partner with detoxification services (inpatient/residential) which have the capacity to maintain participants opioid-free for approximately 3-7 days, have the capacity to provide medication-assisted therapy, and can provide a minimum of one group or individual counseling session per week during the 24-week treatment period. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid). To maximize generalizability, the point of randomization is flexible, from shortly after program admission until just prior to program discharge. A data analysis modification (assessment of whether the early vs. late randomizers have a differential treatment effect and if so, time to relapse will be estimated for early and late randomizers separately) will occur if differential treatment initiation is a problem for cases randomized prior to completing detoxification (i.e., significantly fewer early randomizers are able to complete detoxification and XR-NTX induction). The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e., loss of persistent abstinence) during the 6-month trial. The primary outcome measure will be the time to the event, with the event called relapse. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments. Toward the end of the 24-week treatment period, participants are referred for follow-up care in the community (which could include pharmacotherapy if desired and available), and follow-up outcomes are assessed at week 28 and week 36 after randomization. For participants receiving BUP-NX, who do not wish to continue, or for whom community resources are not available, the study provides a two-week BUP-NX taper. In an ancillary genetics study we plan to study functional variants in three genes (OPRM1, OPRK1 and PDYN), known to affect the dynamic response to opioid receptor ligands. These variants will be evaluated in CTN-0051 for their contribution to treatment retention, abstinence, and depression. Blood collection for DNA extraction will occur at the same time that blood is collected for medical safety and liver function evaluation, precluding the need for an additional needle-stick. Coded blood samples for the genetics studies will be sent to the NIDA Center for Genetics Repository.
Interventions
Extended-Release Naltrexone (Vivitrol®)
Buprenorphine-Naloxone (Suboxone®)
Sponsors
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * 18 years of age and older * Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids) * Have used opioids other than as specifically prescribed within thirty days prior to consent * Seeking treatment for opioid dependence and willing to accept agonist-based or antagonist-based therapy * In good-enough general health, as determined by the study physician on the basis of medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX * Able to provide written informed consent * Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study * If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study
Exclusion criteria
* Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study. Examples include: 1. Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments; 2. Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview; 3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included) * LFTs (ALT, AST) greater than 5 times upper limit of normal * Suicidal or homicidal ideation that requires immediate attention * Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent * Maintenance on methadone at doses of 30mg or greater at the time of signing consent * Presence of pain of sufficient severity as to require ongoing pain management with opioids * Pending legal action or other reasons that might prevent an individual from completing the study * If female, currently pregnant or breastfeeding, or planning on conception * Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI\>40, excess fat tissue over the buttocks, emaciation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse (Intent to Treat Population) | Weeks 3-24 | Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week. |
| Time to Relapse (Per Protocol Population) | Weeks 3-24 | Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Related to Study Medications | Weeks 0-36 | Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor. |
| Opioid Abstinence Over Time While on Study Medication (Subjective) | Weeks 0-24 | Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter. |
| Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0 | Week 0 | Alcohol use over time, drinks per day, past 30 days, at week 0 |
| Cigarette Smoking, W0, 10 or Less | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less. |
| Opioid Craving Over Time W0 | Week 0 | Opioid craving over time via VAS at week 0 |
| Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale | Week 0 | The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression. |
| Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale | Week 0 | The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. |
| Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | Week 0 | The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior. |
| Score on Trail Making Test Part A | Week 0 | Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment. |
| Opioid Abstinence Over Time While on Study Medication (Objective) | Weeks 0-24 | A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits. |
| Cigarette Smoking, W0 0 | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals none |
| Cigarette Smoking, W0 11-20 | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20. |
| Cigarette Smoking, W0 31 or More | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more |
| Cigarette Smoking, W24 0 | Week 24 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals none |
| Cigarette Smoking | Week 24 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less. |
| Cigarette Smoking, W24 11-20 | Week 24 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20. |
| Cigarette Smoking, W24 21-30 | Week 24 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30 |
| Cigarette Smoking, W24 31 or More | Week 24 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more |
| Score on Opioid Craving Scale (OCS) | Week 24 | OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates. |
| Score on Subjective Opiate Withdrawal Scale (SOWS) | Week 0 | The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal. |
| Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | Week 0 | The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior. |
| Score on Trail Making Test Part B | Week 0 | Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task. |
| Score on Word Card of Stoop Test | Week 0 | The word card of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card. |
| Score on Color Card of Stoop Test | Week 0 | The color card contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors. |
| Score on Color Word Card of Stoop Test | Week 0 | The color-word card contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors. |
| Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale | Week 0 | The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. |
| Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale | Week 0 | The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem. |
| Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale | Week 24 | The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem. |
| Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale | Week 0 | The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. |
| Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale | Week 0 | The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. |
| Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale | Week 0 | The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. |
| Score on EuroQOL EQ-5D Questionnaire | Week 0 | Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems. |
| Alcohol Use Over Time, Drinks Per Day | Week 24 | Alcohol use over time, drinks per day |
| Other Drug Use Over Time, Cannabis, W0 | week 0 | Other drug use over time measuring cannabis at week 0 |
| Other Drug Use Over Time, Cannabis, W24 | week 24 | Other drug use over time measuring cannabis at week 24 |
| Cigarette Smoking, W0 21-30 | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30 |
| Other Drug Use Over Time, Cocaine, W24 | week 24 | Other drug use over time measuring cocaine at week 0 |
| Other Drug Use Over Time, Stimulant, W0 | week 0 | Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0 |
| Other Drug Use Over Time, Stimulant, W24 | week 24 | Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24 |
| Other Drug Use Over Time, Cocaine, W0 | week 0 | Other drug use over time measuring cocaine at week 0 |
| Number Successfully Inducted Onto Assigned Study Medication | Weeks 0-24 | Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extended-Release Naltrexone Extended-Release Naltrexone (Vivitrol)
Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®) | 283 |
| Buprenorphine-Naloxone Buprenorphine-Naloxone (Suboxone)
Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®) | 287 |
| Total | 570 |
Baseline characteristics
| Characteristic | Extended-Release Naltrexone | Total | Buprenorphine-Naloxone |
|---|---|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 9.5 | 33.9 years STANDARD_DEVIATION 9.63 | 33.7 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 99 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 238 Participants | 471 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 9 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 57 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 32 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 47 Participants | 27 Participants |
| Race (NIH/OMB) White | 206 Participants | 421 Participants | 215 Participants |
| Randomization status Early randomization | 107 Participants | 217 Participants | 110 Participants |
| Randomization status Late randomization | 176 Participants | 353 Participants | 177 Participants |
| Sex: Female, Male Female | 88 Participants | 169 Participants | 81 Participants |
| Sex: Female, Male Male | 195 Participants | 401 Participants | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 283 | 4 / 287 |
| other Total, other adverse events | 118 / 283 | 135 / 287 |
| serious Total, serious adverse events | 41 / 283 | 31 / 287 |
Outcome results
Primary
Time to Relapse (Intent to Treat Population)
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Time frame: Weeks 3-24
Population: Intention to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Extended-Release Naltrexone | Time to Relapse (Intent to Treat Population) | 8.4 weeks |
| Buprenorphine-Naloxone | Time to Relapse (Intent to Treat Population) | 14.4 weeks |
Primary
Time to Relapse (Per Protocol Population)
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Time frame: Weeks 3-24
Population: Per protocol population (those successfully inducted onto medication)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Extended-Release Naltrexone | Time to Relapse (Per Protocol Population) | 20.4 weeks |
| Buprenorphine-Naloxone | Time to Relapse (Per Protocol Population) | 15.2 weeks |
Secondary
Adverse Events Related to Study Medications
Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.
Time frame: Weeks 0-36
Population: These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended-Release Naltrexone | Adverse Events Related to Study Medications | 115 events |
| Buprenorphine-Naloxone | Adverse Events Related to Study Medications | 113 events |
Secondary
Alcohol Use Over Time, Drinks Per Day
Alcohol use over time, drinks per day
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Alcohol Use Over Time, Drinks Per Day | .1 drinks per day | Standard Deviation 0.82 |
| Buprenorphine-Naloxone | Alcohol Use Over Time, Drinks Per Day | .4 drinks per day | Standard Deviation 1.57 |
Secondary
Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0
Alcohol use over time, drinks per day, past 30 days, at week 0
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0 | .8 drinks per day | Standard Deviation 2.41 |
| Buprenorphine-Naloxone | Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0 | 1.2 drinks per day | Standard Deviation 3.75 |
Secondary
Cigarette Smoking
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less.
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking | 70 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking | 78 Participants |
Secondary
Cigarette Smoking, W0 0
Participants average cigarettes/day, in past 4 weeks, at week 0, equals none
Time frame: Week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W0 0 | 17 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W0 0 | 18 Participants |
Secondary
Cigarette Smoking, W0, 10 or Less
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less.
Time frame: Week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W0, 10 or Less | 112 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W0, 10 or Less | 109 Participants |
Secondary
Cigarette Smoking, W0 11-20
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20.
Time frame: Week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W0 11-20 | 106 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W0 11-20 | 112 Participants |
Secondary
Cigarette Smoking, W0 21-30
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30
Time frame: Week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W0 21-30 | 18 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W0 21-30 | 21 Participants |
Secondary
Cigarette Smoking, W0 31 or More
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more
Time frame: Week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W0 31 or More | 3 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W0 31 or More | 8 Participants |
Secondary
Cigarette Smoking, W24 0
Participants average cigarettes/day, in past 4 weeks, at week 24, equals none
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W24 0 | 32 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W24 0 | 29 Participants |
Secondary
Cigarette Smoking, W24 11-20
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20.
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W24 11-20 | 57 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W24 11-20 | 71 Participants |
Secondary
Cigarette Smoking, W24 21-30
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W24 21-30 | 2 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W24 21-30 | 11 Participants |
Secondary
Cigarette Smoking, W24 31 or More
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Cigarette Smoking, W24 31 or More | 1 Participants |
| Buprenorphine-Naloxone | Cigarette Smoking, W24 31 or More | 5 Participants |
Secondary
Number Successfully Inducted Onto Assigned Study Medication
Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.
Time frame: Weeks 0-24
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended-Release Naltrexone | Number Successfully Inducted Onto Assigned Study Medication | 204 participants |
| Buprenorphine-Naloxone | Number Successfully Inducted Onto Assigned Study Medication | 270 participants |
Secondary
Opioid Abstinence Over Time While on Study Medication (Objective)
A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.
Time frame: Weeks 0-24
Population: Per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Extended-Release Naltrexone | Opioid Abstinence Over Time While on Study Medication (Objective) | 13 Weeks |
| Buprenorphine-Naloxone | Opioid Abstinence Over Time While on Study Medication (Objective) | 11 Weeks |
Secondary
Opioid Abstinence Over Time While on Study Medication (Subjective)
Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.
Time frame: Weeks 0-24
Population: per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Extended-Release Naltrexone | Opioid Abstinence Over Time While on Study Medication (Subjective) | 123 days |
| Buprenorphine-Naloxone | Opioid Abstinence Over Time While on Study Medication (Subjective) | 87 days |
Secondary
Opioid Craving Over Time W0
Opioid craving over time via VAS at week 0
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Opioid Craving Over Time W0 | 68.7 score on a scale | Standard Deviation 30.55 |
| Buprenorphine-Naloxone | Opioid Craving Over Time W0 | 68.8 score on a scale | Standard Deviation 30.05 |
Secondary
Other Drug Use Over Time, Cannabis, W0
Other drug use over time measuring cannabis at week 0
Time frame: week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Other Drug Use Over Time, Cannabis, W0 | 123 Participants |
| Buprenorphine-Naloxone | Other Drug Use Over Time, Cannabis, W0 | 135 Participants |
Secondary
Other Drug Use Over Time, Cannabis, W24
Other drug use over time measuring cannabis at week 24
Time frame: week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Other Drug Use Over Time, Cannabis, W24 | 20 Participants |
| Buprenorphine-Naloxone | Other Drug Use Over Time, Cannabis, W24 | 20 Participants |
Secondary
Other Drug Use Over Time, Cocaine, W0
Other drug use over time measuring cocaine at week 0
Time frame: week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Other Drug Use Over Time, Cocaine, W0 | 61 Participants |
| Buprenorphine-Naloxone | Other Drug Use Over Time, Cocaine, W0 | 80 Participants |
Secondary
Other Drug Use Over Time, Cocaine, W24
Other drug use over time measuring cocaine at week 0
Time frame: week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Other Drug Use Over Time, Cocaine, W24 | 5 Participants |
| Buprenorphine-Naloxone | Other Drug Use Over Time, Cocaine, W24 | 2 Participants |
Secondary
Other Drug Use Over Time, Stimulant, W0
Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0
Time frame: week 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Other Drug Use Over Time, Stimulant, W0 | 132 Participants |
| Buprenorphine-Naloxone | Other Drug Use Over Time, Stimulant, W0 | 166 Participants |
Secondary
Other Drug Use Over Time, Stimulant, W24
Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24
Time frame: week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended-Release Naltrexone | Other Drug Use Over Time, Stimulant, W24 | 5 Participants |
| Buprenorphine-Naloxone | Other Drug Use Over Time, Stimulant, W24 | 3 Participants |
Secondary
Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.11 |
| Buprenorphine-Naloxone | Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale | 0.0 score on a scale | Standard Deviation 0.11 |
Secondary
Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.2 |
| Buprenorphine-Naloxone | Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.23 |
Secondary
Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | 3.6 score on a scale | Standard Deviation 7.34 |
| Buprenorphine-Naloxone | Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | 4.3 score on a scale | Standard Deviation 10.07 |
Secondary
Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | 4.8 score on a scale | Standard Deviation 8.4 |
| Buprenorphine-Naloxone | Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | 4.3 score on a scale | Standard Deviation 10.34 |
Secondary
Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale | 0.3 score on a scale | Standard Deviation 0.08 |
| Buprenorphine-Naloxone | Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale | .3 score on a scale | Standard Deviation 0.09 |
Secondary
Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.13 |
| Buprenorphine-Naloxone | Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.12 |
Secondary
Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.18 |
| Buprenorphine-Naloxone | Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.19 |
Secondary
Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.17 |
| Buprenorphine-Naloxone | Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.17 |
Secondary
Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale | .2 score on a scale | Standard Deviation 0.21 |
| Buprenorphine-Naloxone | Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale | .2 score on a scale | Standard Deviation 0.21 |
Secondary
Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale | .1 score on a scale | Standard Deviation 0.24 |
| Buprenorphine-Naloxone | Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale | .2 score on a scale | Standard Deviation 0.25 |
Secondary
Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale | .2 score on a scale | Standard Deviation 0.25 |
| Buprenorphine-Naloxone | Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale | .2 score on a scale | Standard Deviation 0.27 |
Secondary
Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale | .3 score on a scale | Standard Deviation 0.22 |
| Buprenorphine-Naloxone | Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale | .3 score on a scale | Standard Deviation 0.22 |
Secondary
Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale | .2 score on a scale | Standard Deviation 0.21 |
| Buprenorphine-Naloxone | Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale | .2 score on a scale | Standard Deviation 0.21 |
Secondary
Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | 5.5 score on a scale | Standard Deviation 8.85 |
| Buprenorphine-Naloxone | Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | 5.9 score on a scale | Standard Deviation 10.46 |
Secondary
Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | 7.3 score on a scale | Standard Deviation 9.37 |
| Buprenorphine-Naloxone | Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | 6.0 score on a scale | Standard Deviation 10.63 |
Secondary
Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale | .3 score on a scale | Standard Deviation 0.25 |
| Buprenorphine-Naloxone | Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale | .3 score on a scale | Standard Deviation 0.24 |
Secondary
Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale | 5.2 score on a scale | Standard Deviation 6.53 |
| Buprenorphine-Naloxone | Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale | 4.8 score on a scale | Standard Deviation 5.48 |
Secondary
Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale | 8.6 score on a scale | Standard Deviation 6.45 |
| Buprenorphine-Naloxone | Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale | 9.3 score on a scale | Standard Deviation 6.63 |
Secondary
Score on Color Card of Stoop Test
The color card contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Color Card of Stoop Test | 75.3 seconds | Standard Deviation 15.31 |
| Buprenorphine-Naloxone | Score on Color Card of Stoop Test | 76.1 seconds | Standard Deviation 14.84 |
Secondary
Score on Color Card of Stoop Test
The color card contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Color Card of Stoop Test | 69.3 seconds | Standard Deviation 13.63 |
| Buprenorphine-Naloxone | Score on Color Card of Stoop Test | 70.5 seconds | Standard Deviation 12.46 |
Secondary
Score on Color Word Card of Stoop Test
The color-word card contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Color Word Card of Stoop Test | 41.1 seconds | Standard Deviation 10.33 |
| Buprenorphine-Naloxone | Score on Color Word Card of Stoop Test | 42.2 seconds | Standard Deviation 9.85 |
Secondary
Score on Color Word Card of Stoop Test
The color-word card contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Color Word Card of Stoop Test | 47.6 seconds | Standard Deviation 12.07 |
| Buprenorphine-Naloxone | Score on Color Word Card of Stoop Test | 48.8 seconds | Standard Deviation 12.35 |
Secondary
Score on EuroQOL EQ-5D Questionnaire
Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on EuroQOL EQ-5D Questionnaire | 6.8 score on a scale | Standard Deviation 1.44 |
| Buprenorphine-Naloxone | Score on EuroQOL EQ-5D Questionnaire | 6.8 score on a scale | Standard Deviation 1.31 |
Secondary
Score on EuroQOL EQ-5D Questionnaire
Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on EuroQOL EQ-5D Questionnaire | 5.8 score on a scale | Standard Deviation 1.15 |
| Buprenorphine-Naloxone | Score on EuroQOL EQ-5D Questionnaire | 6.1 score on a scale | Standard Deviation 1.28 |
Secondary
Score on Opioid Craving Scale (OCS)
OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Opioid Craving Scale (OCS) | 9.9 score on a scale | Standard Deviation 21.54 |
| Buprenorphine-Naloxone | Score on Opioid Craving Scale (OCS) | 9.4 score on a scale | Standard Deviation 17.67 |
Secondary
Score on Subjective Opiate Withdrawal Scale (SOWS)
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Subjective Opiate Withdrawal Scale (SOWS) | 15.6 score on a scale | Standard Deviation 13.38 |
| Buprenorphine-Naloxone | Score on Subjective Opiate Withdrawal Scale (SOWS) | 15.6 score on a scale | Standard Deviation 13.15 |
Secondary
Score on Subjective Opiate Withdrawal Scale (SOWS)
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Subjective Opiate Withdrawal Scale (SOWS) | 4.5 score on a scale | Standard Deviation 7.53 |
| Buprenorphine-Naloxone | Score on Subjective Opiate Withdrawal Scale (SOWS) | 5.3 score on a scale | Standard Deviation 7.49 |
Secondary
Score on Trail Making Test Part A
Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Trail Making Test Part A | 26.8 seconds | Standard Deviation 11.09 |
| Buprenorphine-Naloxone | Score on Trail Making Test Part A | 25.8 seconds | Standard Deviation 10.07 |
Secondary
Score on Trail Making Test Part A
Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Trail Making Test Part A | 21.6 seconds | Standard Deviation 9.81 |
| Buprenorphine-Naloxone | Score on Trail Making Test Part A | 20.3 seconds | Standard Deviation 7.03 |
Secondary
Score on Trail Making Test Part B
Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Trail Making Test Part B | 79.1 seconds | Standard Deviation 40.19 |
| Buprenorphine-Naloxone | Score on Trail Making Test Part B | 78.3 seconds | Standard Deviation 40.73 |
Secondary
Score on Trail Making Test Part B
Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Trail Making Test Part B | 61.2 seconds | Standard Deviation 39.32 |
| Buprenorphine-Naloxone | Score on Trail Making Test Part B | 58.1 seconds | Standard Deviation 33.37 |
Secondary
Score on Word Card of Stoop Test
The word card of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Word Card of Stoop Test | 95.8 seconds | Standard Deviation 16.6 |
| Buprenorphine-Naloxone | Score on Word Card of Stoop Test | 96.4 seconds | Standard Deviation 16.03 |
Secondary
Score on Word Card of Stoop Test
The word card of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended-Release Naltrexone | Score on Word Card of Stoop Test | 103.2 seconds | Standard Deviation 18.02 |
| Buprenorphine-Naloxone | Score on Word Card of Stoop Test | 102.9 seconds | Standard Deviation 19.7 |