Trial · NCT02617628
Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
NCT02617628, Phase 2, Phase 3, Completed, University of Pennsylvania; results first posted 2020-04-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone. Trials, record NCT02617628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02617628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
- NCT number
- NCT02617628
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 146 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Opiate Dependence
- Interventions
- extended release naltrexone
- First posted
- 2015-12-01
- Last updated
- 2021-01-28
- Results first posted
- 2020-04-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Reincarceration | 0 to 28 months | percentage of patients who were reincarcerated |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relapse to Opioid Use in Subjects by Month 3 | 12 weeks (month 3) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Reincarceration | 0 to 28 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relapse to Opioid Use in Subjects by Month 3 | Before Re-entry | 16 | Participants | ||
| Relapse to Opioid Use in Subjects by Month 3 | After Re-entry | 20 | Participants | ||
| Reincarceration | Before Re-entry | 28 | Participants | ||
| Reincarceration | After Re-entry | 22 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Before Re-entry | 74 | |
| Overall Study | STARTED | After Re-entry | 72 | |
| Overall Study | COMPLETED | Before Re-entry | 12 | |
| Overall Study | COMPLETED | After Re-entry | 11 | |
| Overall Study | NOT COMPLETED | Before Re-entry | 62 | |
| Overall Study | NOT COMPLETED | After Re-entry | 61 |
Source ClinicalTrials.gov
Adverse events130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | Before Re-entry | 1 | 74 | 1 |
| other | abdominal pain | Gastrointestinal disorders | After Re-entry | 0 | 72 | 0 |
| other | anxiety | Psychiatric disorders | Before Re-entry | 6 | 74 | 6 |
| other | anxiety | Psychiatric disorders | After Re-entry | 3 | 72 | 3 |
| other | anxiousness | Psychiatric disorders | Before Re-entry | 5 | 74 | 5 |
| other | anxiousness | Psychiatric disorders | After Re-entry | 0 | 72 | 0 |
| other | back pain | Musculoskeletal and connective tissue disorders | Before Re-entry | 4 | 74 | 5 |
| other | back pain | Musculoskeletal and connective tissue disorders | After Re-entry | 1 | 72 | 1 |
| other | back pain-lower | Musculoskeletal and connective tissue disorders | Before Re-entry | 1 | 74 | 2 |
| other | back pain-lower | Musculoskeletal and connective tissue disorders | After Re-entry | 0 | 72 | 0 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Before Re-entry | 1 | 74 |
| Total, all-cause mortality | After Re-entry | 3 | 72 |
| Total, other adverse events | Before Re-entry | 35 | 74 |
| Total, other adverse events | After Re-entry | 21 | 72 |
| Total, serious adverse events | Before Re-entry | 10 | 74 |
| Total, serious adverse events | After Re-entry | 13 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37231479 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Before Re-entry vs After Re-entry: Reincarceration | Trial comparisons |
| Before Re-entry vs After Re-entry: Relapse to Opioid Use in Subjects by Month 3 | Trial comparisons |
| Before Re-entry vs After Re-entry: deaths from any cause | Trial comparisons |
| Before Re-entry vs After Re-entry: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02617628
GET https://conductscience.org/api/trials/v1/NCT02617628/events?page=2