Trial Outcomes & Findings for Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (NCT NCT02617628)

Last Updated: 2021-01-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

146 participants

Primary outcome timeframe

12 weeks (month 3)

Results posted on

2021-01-28

Participant Flow

Recruitment started August 2016 and ended June 16, 2018 in the Philadelphia Prison System. Subjects all were recruited while incarcerated.

Subjects were stratified to sentenced/not sentenced and male/female

Participant milestones

Participant milestones
Measure	Before Re-entry Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.	After Re-entry Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
Overall Study STARTED	74	72
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	62	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Before Re-entry Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.	After Re-entry Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
Overall Study Withdr, Transfers-other prisons, dropout	62	61

Baseline Characteristics

Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	After Re-entry n=74 Participants 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.	Before Re-entry n=72 Participants 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.	Total n=146 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.7 years STANDARD_DEVIATION 10.0 • n=5 Participants	36.2 years STANDARD_DEVIATION 8.5 • n=7 Participants	37.0 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	52 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	54 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	61 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	74 participants n=5 Participants	72 participants n=7 Participants	146 participants n=5 Participants
Opioid Drug Use	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants
EuroQol Overall Health Mobility · No Problems	69 Participants n=5 Participants	60 Participants n=7 Participants	129 Participants n=5 Participants
EuroQol Overall Health Mobility · Slight Problems	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
EuroQol Overall Health Mobility · Moderate Problems	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
EuroQol Overall Health Mobility · Severe Problems	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
EuroQol Overall Health Mobility · x=Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
EuroQol Overall Health Self Care · No Problems	71 Participants n=5 Participants	67 Participants n=7 Participants	138 Participants n=5 Participants
EuroQol Overall Health Self Care · Slight Problems	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
EuroQol Overall Health Self Care · Moderate Problems	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
EuroQol Overall Health Self Care · Severe Problems	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
EuroQol Overall Health Self Care · x=Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
EuroQol Overall Health Doing Usual Activities · No Problems	65 Participants n=5 Participants	59 Participants n=7 Participants	124 Participants n=5 Participants
EuroQol Overall Health Doing Usual Activities · Slight Problems	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
EuroQol Overall Health Doing Usual Activities · Moderate Problems	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
EuroQol Overall Health Doing Usual Activities · Severe Problems	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
EuroQol Overall Health Doing Usual Activities · x=Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
EuroQol Overall Health Pain or Discomfort · No Problems	42 Participants n=5 Participants	35 Participants n=7 Participants	77 Participants n=5 Participants
EuroQol Overall Health Pain or Discomfort · Slight Problems	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
EuroQol Overall Health Pain or Discomfort · Moderate Problems	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
EuroQol Overall Health Pain or Discomfort · Severe Problems	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
EuroQol Overall Health Pain or Discomfort · x=Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
EuroQol Overall Health Anxiety and Depression · No Problems	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
EuroQol Overall Health Anxiety and Depression · Slight Problems	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
EuroQol Overall Health Anxiety and Depression · Moderate Problems	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
EuroQol Overall Health Anxiety and Depression · Severe Problems	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
EuroQol Overall Health Anxiety and Depression · x=Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Beck Depression Index No Depression	44 Participants n=5 Participants	39 Participants n=7 Participants	83 Participants n=5 Participants
Beck Depression Index Clinical Depression	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Beck Depression Index Missing	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Timeline Follow-Back Heroin Use	21.91 days STANDARD_DEVIATION 12.6 • n=5 Participants	25.56 days STANDARD_DEVIATION 9.59 • n=7 Participants	23.71 days STANDARD_DEVIATION 11.3 • n=5 Participants
Timeline Follow-Back Methadone Use	.92 days STANDARD_DEVIATION 4.7 • n=5 Participants	1.19 days STANDARD_DEVIATION 4.9 • n=7 Participants	1.05 days STANDARD_DEVIATION 4.7 • n=5 Participants
Timeline Follow-Back Other Opioids	8.46 days STANDARD_DEVIATION 12.05 • n=5 Participants	6.97 days STANDARD_DEVIATION 11.06 • n=7 Participants	7.73 days STANDARD_DEVIATION 11.56 • n=5 Participants
Timeline Follow-Back Benzodiazepines	6.36 days STANDARD_DEVIATION 10.59 • n=5 Participants	7.78 days STANDARD_DEVIATION 11.11 • n=7 Participants	7.06 days STANDARD_DEVIATION 10.84 • n=5 Participants
Timeline Follow-Back Cocaine	12.7 days STANDARD_DEVIATION 13.01 • n=5 Participants	14.19 days STANDARD_DEVIATION 13.27 • n=7 Participants	13.44 days STANDARD_DEVIATION 13.11 • n=5 Participants
Risk Assessment Battery Drug Risk Score	3.19 units on a scale STANDARD_DEVIATION 4.33 • n=5 Participants	4.42 units on a scale STANDARD_DEVIATION 4.87 • n=7 Participants	3.79 units on a scale STANDARD_DEVIATION 4.6 • n=5 Participants
Risk Assessment Battery Sex Risk Scoe	5.61 units on a scale STANDARD_DEVIATION 2.89 • n=5 Participants	5.94 units on a scale STANDARD_DEVIATION 2.66 • n=7 Participants	5.77 units on a scale STANDARD_DEVIATION 2.77 • n=5 Participants
Risk Assessment Battery Total RAB Score	8.80 units on a scale STANDARD_DEVIATION 6.17 • n=5 Participants	10.36 units on a scale STANDARD_DEVIATION 6.68 • n=7 Participants	9.57 units on a scale STANDARD_DEVIATION 6.45 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Before Re-entry n=38 Participants Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months. intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.	After Re-entry n=48 Participants Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), After they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months. outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
Relapse to Opioid Use in Subjects by Month 3	16 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

percentage of patients who were reincarcerated

Outcome measures

Outcome measures
Measure	Before Re-entry n=38 Participants Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months. intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.	After Re-entry n=48 Participants Extended Release Naltrexone, 380 mg injection Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), After they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months. outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
Reincarceration	28 Participants	22 Participants

Adverse Events

Before Re-entry

Serious events: 10 serious events

Other events: 35 other events

Deaths: 1 deaths

After Re-entry

Serious events: 13 serious events

Other events: 21 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Before Re-entry n=74 participants at risk Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months 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. 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.	After Re-entry n=72 participants at risk Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months 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 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.
Respiratory, thoracic and mediastinal disorders overdose	9.5% 7/74 • Number of events 7 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.	12.5% 9/72 • Number of events 9 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
Gastrointestinal disorders abdominal pain	1.4% 1/74 • Number of events 1 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.	0.00% 0/72 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
Renal and urinary disorders kidney pain	2.7% 2/74 • Number of events 2 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.	0.00% 0/72 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
Psychiatric disorders panic attack	0.00% 0/74 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.	1.4% 1/72 • Number of events 1 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
Musculoskeletal and connective tissue disorders broken rib	0.00% 0/74 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.	1.4% 1/72 • Number of events 1 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
Psychiatric disorders suicidal ideation	0.00% 0/74 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.	1.4% 1/72 • Number of events 1 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
Pregnancy, puerperium and perinatal conditions pregnancy	0.00% 0/74 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.	1.4% 1/72 • Number of events 1 • 2 years, 2 months The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.

Other adverse events

Additional Information

W. Stuart Watson

University of Pennsylvania Office of Research Services

Phone: 215-573-6707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place