Opiate Dependence
Conditions
Keywords
opioid addiction
Brief summary
This study is a collaboration between the University of Pennsylvania, the Philadelphia Prison System, and the North East Treatment Center (NETSteps). It purpose is to study the impact of an injectable opiate addiction medication (extended release naltrexone) given before reentry into the community that might help to improve reconnection to healthcare and other support systems, and possibly help reduce recidivism.
Detailed description
The primary objectives for this study is to offer tools to support improve healthcare and related outcomes and reduce the risk of relapse and recidivism for opiate addicted prisoners reentering into the community after release from correctional facilities. In this study the investigators examine a medication-assisted therapy (extended release naltrexone) that is likely to be acceptable to correctional facilities and opioid addicted prisoners and that can improve the outcomes achieved by the usual detoxification/treatment referral approach. The results may be used to facilitate policy changes that involve adding extended release naltrexone to correctional facility formularies for use before reentry, and collaborating with one or more outpatient treatment providers to maintain continuity of care. Two hundred (200) opioid addicted prisoners currently incarcerated in the Philadelphia Prison System, who meet study admission criteria and express an interest in extended release naltrexone treatment, who give informed consent and will be scheduled for release within 14 days of being randomized into the study will be enrolled. These 200 subjects will be stratified by sex (male/females), will be 18 years or older, and are not sentenced).
Interventions
Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison, or either 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.
Sponsors
Patient-Centered Outcomes Research Institute
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Opioid dependent with physiological features according to Diagnostic and Statistical Manual of Mental Disorders-5th edition * Interested in extended release naltrexone treatment * Eligible to have health benefits reinstated * Detoxified and able to pass a naloxone challenge (e.g. no withdrawal within 30 minutes after receiving 0.8 mg naloxone I.M. and documented by a score \<5 on the Clinical Opiate Withdrawal Scale * Age 18 or above * Not being transferred to serve a longer sentence in a State or Federal prison * Provide their address or phone number along with the names and contact information of 3 or more persons likely to know where they can be reached with permission to contact them if unable to be reached in other ways * Able to speak and read English and provide informed consent * able to correctly answer 9 of 10 study quiz items * not pregnant and agree to the use of an acceptable form of birth control * can access to NET Steps via car or public or other transportation after reentry
Exclusion criteria
* Planning to move from the Philadelphia area within the next 6 months * Neurological, cardiovascular, renal, hepatic (Alanine aminotransferase, Aspartate aminotransferase or Gamma-glutamyl transpeptidase \>3 times top limit of normal) or another medical disorder that seriously impairs or makes hazardous ability to participate * Active tuberculosis * Currently psychotic, homicidal, suicidal * Uncontrolled seizure disorder * History of allergy to naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or any other components of the diluent * Chronic pain for which opioids are needed * Sentenced to naltrexone Treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse to Opioid Use in Subjects by Month 3 | 12 weeks (month 3) | Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reincarceration | 0 to 28 months | percentage of patients who were reincarcerated |
Countries
United States
Participant flow
Recruitment details
Recruitment started August 2016 and ended June 16, 2018 in the Philadelphia Prison System. Subjects all were recruited while incarcerated.
Pre-assignment details
Subjects were stratified to sentenced/not sentenced and male/female
Participants by arm
| Arm | Count |
|---|---|
| After Re-entry Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Extended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone after they were released from prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling. | 74 |
| Before Re-entry Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Extended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they left the prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling. | 72 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdr, Transfers-other prisons, dropout | 62 | 61 |
Baseline characteristics
| Characteristic | After Re-entry | Before Re-entry | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 72 Participants | 146 Participants |
| Age, Continuous | 37.7 years STANDARD_DEVIATION 10 | 36.2 years STANDARD_DEVIATION 8.5 | 37.0 years STANDARD_DEVIATION 9.3 |
| Beck Depression Index Clinical Depression | 30 Participants | 31 Participants | 61 Participants |
| Beck Depression Index Missing | 0 Participants | 2 Participants | 2 Participants |
| Beck Depression Index No Depression | 44 Participants | 39 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 18 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 54 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| EuroQol Overall Health Anxiety and Depression Moderate Problems | 15 Participants | 21 Participants | 36 Participants |
| EuroQol Overall Health Anxiety and Depression No Problems | 18 Participants | 21 Participants | 39 Participants |
| EuroQol Overall Health Anxiety and Depression Severe Problems | 14 Participants | 7 Participants | 21 Participants |
| EuroQol Overall Health Anxiety and Depression Slight Problems | 27 Participants | 22 Participants | 49 Participants |
| EuroQol Overall Health Anxiety and Depression x=Missing | 0 Participants | 1 Participants | 1 Participants |
| EuroQol Overall Health Doing Usual Activities Moderate Problems | 4 Participants | 3 Participants | 7 Participants |
| EuroQol Overall Health Doing Usual Activities No Problems | 65 Participants | 59 Participants | 124 Participants |
| EuroQol Overall Health Doing Usual Activities Severe Problems | 0 Participants | 1 Participants | 1 Participants |
| EuroQol Overall Health Doing Usual Activities Slight Problems | 5 Participants | 8 Participants | 13 Participants |
| EuroQol Overall Health Doing Usual Activities x=Missing | 0 Participants | 1 Participants | 1 Participants |
| EuroQol Overall Health Mobility Moderate Problems | 1 Participants | 7 Participants | 8 Participants |
| EuroQol Overall Health Mobility No Problems | 69 Participants | 60 Participants | 129 Participants |
| EuroQol Overall Health Mobility Severe Problems | 1 Participants | 0 Participants | 1 Participants |
| EuroQol Overall Health Mobility Slight Problems | 3 Participants | 4 Participants | 7 Participants |
| EuroQol Overall Health Mobility x=Missing | 0 Participants | 1 Participants | 1 Participants |
| EuroQol Overall Health Pain or Discomfort Moderate Problems | 13 Participants | 12 Participants | 25 Participants |
| EuroQol Overall Health Pain or Discomfort No Problems | 42 Participants | 35 Participants | 77 Participants |
| EuroQol Overall Health Pain or Discomfort Severe Problems | 4 Participants | 4 Participants | 8 Participants |
| EuroQol Overall Health Pain or Discomfort Slight Problems | 15 Participants | 20 Participants | 35 Participants |
| EuroQol Overall Health Pain or Discomfort x=Missing | 0 Participants | 1 Participants | 1 Participants |
| EuroQol Overall Health Self Care Moderate Problems | 1 Participants | 2 Participants | 3 Participants |
| EuroQol Overall Health Self Care No Problems | 71 Participants | 67 Participants | 138 Participants |
| EuroQol Overall Health Self Care Severe Problems | 0 Participants | 0 Participants | 0 Participants |
| EuroQol Overall Health Self Care Slight Problems | 2 Participants | 2 Participants | 4 Participants |
| EuroQol Overall Health Self Care x=Missing | 0 Participants | 1 Participants | 1 Participants |
| Opioid Drug Use | 74 Participants | 72 Participants | 146 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 10 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 61 Participants | 115 Participants |
| Region of Enrollment United States | 74 participants | 72 participants | 146 participants |
| Risk Assessment Battery Drug Risk Score | 3.19 units on a scale STANDARD_DEVIATION 4.33 | 4.42 units on a scale STANDARD_DEVIATION 4.87 | 3.79 units on a scale STANDARD_DEVIATION 4.6 |
| Risk Assessment Battery Sex Risk Scoe | 5.61 units on a scale STANDARD_DEVIATION 2.89 | 5.94 units on a scale STANDARD_DEVIATION 2.66 | 5.77 units on a scale STANDARD_DEVIATION 2.77 |
| Risk Assessment Battery Total RAB Score | 8.80 units on a scale STANDARD_DEVIATION 6.17 | 10.36 units on a scale STANDARD_DEVIATION 6.68 | 9.57 units on a scale STANDARD_DEVIATION 6.45 |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 54 Participants | 52 Participants | 106 Participants |
| Timeline Follow-Back Benzodiazepines | 6.36 days STANDARD_DEVIATION 10.59 | 7.78 days STANDARD_DEVIATION 11.11 | 7.06 days STANDARD_DEVIATION 10.84 |
| Timeline Follow-Back Cocaine | 12.7 days STANDARD_DEVIATION 13.01 | 14.19 days STANDARD_DEVIATION 13.27 | 13.44 days STANDARD_DEVIATION 13.11 |
| Timeline Follow-Back Heroin Use | 21.91 days STANDARD_DEVIATION 12.6 | 25.56 days STANDARD_DEVIATION 9.59 | 23.71 days STANDARD_DEVIATION 11.3 |
| Timeline Follow-Back Methadone Use | .92 days STANDARD_DEVIATION 4.7 | 1.19 days STANDARD_DEVIATION 4.9 | 1.05 days STANDARD_DEVIATION 4.7 |
| Timeline Follow-Back Other Opioids | 8.46 days STANDARD_DEVIATION 12.05 | 6.97 days STANDARD_DEVIATION 11.06 | 7.73 days STANDARD_DEVIATION 11.56 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 74 | 3 / 72 |
| other Total, other adverse events | 35 / 74 | 21 / 72 |
| serious Total, serious adverse events | 10 / 74 | 13 / 72 |
Outcome results
Primary
Relapse to Opioid Use in Subjects by Month 3
Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.
Time frame: 12 weeks (month 3)
Population: In treatment arm 1 (before reentry) 38 subjects received vivitrol before leaving prison.~In treatment arm 2 (after reentry) 48 subjects were eligible to receive injections after release from prison. Arm 2 subjects were to return to the research clinic within 7 days after release to receive their first injection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Before Re-entry | Relapse to Opioid Use in Subjects by Month 3 | 16 Participants |
| After Re-entry | Relapse to Opioid Use in Subjects by Month 3 | 20 Participants |
Comparison: Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.p-value: 0.3895% CI: [0.57, 4.27]Regression, Logistic
Secondary
Reincarceration
percentage of patients who were reincarcerated
Time frame: 0 to 28 months
Population: This outcome was determined as follows: one XR-NTX injection provided 4 weeks of treatment. Study patients also had counseling, thus weeks in treatment equaled the weeks of protected time from XR-NTX plus the number of weeks a patient had one or more counseling appointments after the protection from the last XR-NTX dose ended.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Before Re-entry | Reincarceration | 28 Participants |
| After Re-entry | Reincarceration | 22 Participants |
Comparison: We used Cox proportional hazards regression model to compare the groups on time to reincarceration.p-value: 0.01Regression, Cox