Drug Dependence
Conditions
Keywords
opioid dependence
Brief summary
The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).
Detailed description
This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a community drug treatment program in Baltimore. TAU will consist of buprenorphine treatment of opioid withdrawal followed by counseling with or without continued buprenorphine.
Interventions
naltrexone for extended release injectable suspension
BEHAVIORALPsychosocial Treatment
Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
DRUGBuprenorphine
Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
Sponsors
National Institute on Drug Abuse (NIDA)
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic subtype; * Within 3 days of admission to MMTC; * Age between 15 and 21, inclusive; * Able and willing to provide informed consent to be randomly assigned to XR- NTX or TAU; and for participants under 18 years of age, parental or guardian consent and participant assent.
Exclusion criteria
* Liver function test levels (Alanine Transaminase, Aspartate Transaminase) four times greater than normal; * Unstable medical or psychiatric illness (e.g., schizophrenia) that might make participation hazardous; * History of serious suicide attempt in the past 6 months; * History of allergic reaction to naloxone, and/or naltrexone; * Current chronic pain condition for which opioids are deemed necessary for ongoing care; * blood coagulation disorder (e.g., hemophilia); * Body Mass Index \> 40; * If female, pregnant, lactating, unwilling or unable (due to parental objection) to use FDA-approved contraceptive methods; * meeting DSM-IV criteria for benzodiazepine dependence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use at 6 Month Follow-up | 6 months | To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Retention | 6 months | To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment. Treatment defined as medications for OUD received in past 30 days at 6-month follow-up. |
| Monetized Healthcare Utilization | 6 months | The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months. |
| HIV Sex Risk Behaviors | 6 months | To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months. Past 90 days self-reported HIV sex risk behaviors on the Risk Assessment Battery (RAB). Minimum value 0; maximum value 24. Higher scores reflect endorsement of more risk behaviors (worse outcome). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extended Release Naltrexone Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX \[Vivitrol®\] at a dose of 4cc (380mg of naltrexone)\] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
Extended Release Naltrexone: naltrexone for extended release injectable suspension
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community. | 144 |
| Treatment as Usual Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
Psychosocial Treatment: Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Buprenorphine: Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study. | 144 |
| Total | 288 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 24 | 29 |
| Overall Study | Withdrawal by Subject | 8 | 6 |
Baseline characteristics
| Characteristic | Extended Release Naltrexone | Treatment as Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 17 Participants | 8 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 127 Participants | 136 Participants | 263 Participants |
| Age, Continuous | 19.18 years STANDARD_DEVIATION 1.3 | 19.46 years STANDARD_DEVIATION 1.2 | 19.32 years STANDARD_DEVIATION 1.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 135 Participants | 273 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 13 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 118 Participants | 121 Participants | 239 Participants |
| Region of Enrollment United States | 144 Participants | 144 Participants | 288 Participants |
| Self-reported opioid use past 90 days | 65.71 days STANDARD_DEVIATION 23.2 | 63.19 days STANDARD_DEVIATION 23.5 | 64.45 days STANDARD_DEVIATION 23.4 |
| Sex: Female, Male Female | 66 Participants | 67 Participants | 133 Participants |
| Sex: Female, Male Male | 78 Participants | 77 Participants | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 144 | 0 / 144 |
| other Total, other adverse events | 132 / 144 | 122 / 144 |
| serious Total, serious adverse events | 5 / 144 | 5 / 144 |
Outcome results
Primary
Opioid Use at 6 Month Follow-up
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Release Naltrexone | Opioid Use at 6 Month Follow-up | 19.63 days | Standard Error 2.55 |
| Treatment as Usual | Opioid Use at 6 Month Follow-up | 18.42 days | Standard Error 2.68 |
Secondary
HIV Sex Risk Behaviors
To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months. Past 90 days self-reported HIV sex risk behaviors on the Risk Assessment Battery (RAB). Minimum value 0; maximum value 24. Higher scores reflect endorsement of more risk behaviors (worse outcome).
Time frame: 6 months
Population: Participants who completed 6-month follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Release Naltrexone | HIV Sex Risk Behaviors | 3.53 score on a scale | Standard Deviation 2.23 |
| Treatment as Usual | HIV Sex Risk Behaviors | 3.42 score on a scale | Standard Deviation 2.34 |
p-value: <0.05t-test, 2 sided
Secondary
Monetized Healthcare Utilization
The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Release Naltrexone | Monetized Healthcare Utilization | 8136 dollars | Standard Error 646.07 |
| Treatment as Usual | Monetized Healthcare Utilization | 6629 dollars | Standard Error 602.55 |
Secondary
Treatment Retention
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment. Treatment defined as medications for OUD received in past 30 days at 6-month follow-up.
Time frame: 6 months
Population: Participants who completed 6-month follow-up assessment with complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Release Naltrexone | Treatment Retention | 5.53 days | Standard Deviation 11.07 |
| Treatment as Usual | Treatment Retention | 4.69 days | Standard Deviation 10.16 |
p-value: <0.05t-test, 2 sided