A Phase 3 interventional study of Buprenorphine +OTP and Buprenorphine +CHC in Heroin Addiction, sponsored by Friends Research Institute, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Friends Research Institute, Inc. · Phase 3, Interventional, and Health services research
This five-year study examines the effectiveness of buprenorphine treatment provided to previously-addicted inmates(N=320; 160 males, 160 females) initiated in prison and continued in the community. The study also examines the extent to which the setting of post-release buprenorphine is provided.It is expected that participants receiving in-prison buprenorphine will have superior outcomes compared to participants who did not receive in-prison buprenorphine.
Participants will be randomly assigned, within gender, to one of four treatment conditions: 1) buprenorphine and counseling in prison, with referral for continued treatment at an OTP upon release; 2) buprenorphine and counseling in prison, with referral for continued treatment at a CHC upon release; 3) counseling only in prison, with referral for buprenorphine and counseling at a OTP upon release; and 4) counseling only in prison, with referral for buprenorphine and counseling at a CHC upon release. Participants will be assessed at study entry and at 1, 3, 6, and 12 months following their release from prison. Outcome measures include: treatment entry and retention in the community, heroin use, cocaine use, HIV infection, HIV-risk behaviors, criminal activity, and employment.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 213 is above the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →Friends Research Institute, Inc. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.
Drug: Buprenorphine +OTP
Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.
Drug: Buprenorphine +CHC
Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)
Drug: Counseling +OTP
Counseling only in prisons and Buprenorphine upon release at a community health center (CHC)
Drug: Counseling +CHC
Drug page: Buprenorphine
Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment (OTP) program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
Also known as: Suboxone
Drug page: Buprenorphine
Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center (CHC). Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
Also known as: Suboxone
Drug page: Buprenorphine
Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
Also known as: Suboxone
Drug page: Buprenorphine
Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
Also known as: Suboxone
Number of Days of Heroin Use
mean days used heroin during the past 30 days
Time frame: 1 year
Drug Abuse Treatment Entry and Retention in the Community
entered community treatment within 10 days of release from prison (yes vs. no)
Time frame: 1 year
Number of Days of Cocaine Use
Number of days used cocaine during the past 30 days.
Time frame: 1 year
Criminal Activity
Days of crime during the past 30 days
Time frame: 1 year
Employment Status
Number of days employed during the past year
Time frame: 1 year
HIV Risk Behavior Needle Sharing
Number of times shared a needle during the past year
Time frame: 1 year
HIV Risk Behavior
Number of times had sex without using a condom during the past year
Time frame: 1 year
| Milestone | Bup+OTP | Bup+CHC | Counseling+OTP | Counseling+CHC |
|---|---|---|---|---|
| Started | 53 | 53 | 54 | 53 |
| Completed | 52 | 52 | 54 | 53 |
| Not completed | 1 | 1 | 0 | 0 |
mean days used heroin during the past 30 days
| days | Bup+OTP | Bup+CHC | Counseling+OTP | Counseling+CHC |
|---|---|---|---|---|
| Number of Days of Heroin Use | 6.0 ± 11.4 | 6.4 ± 11.5 | 6.5 ± 11.3 | 4.0 ± 9.0 |
entered community treatment within 10 days of release from prison (yes vs. no)
| participants | B+OTP | B+CHC | C+OTP | C+CHC |
|---|---|---|---|---|
| Drug Abuse Treatment Entry and Retention in the Community | 22 | 26 | 23 | 11 |
Number of days used cocaine during the past 30 days.
| days | Bup+OTP | Bup+CHC | Counseling+OTP | Counseling+CHC |
|---|---|---|---|---|
| Number of Days of Cocaine Use | 1.1 ± 4.3 | 4.1 ± 9.5 | 4.7 ± 9.4 | 2.7 ± 6.0 |
Days of crime during the past 30 days
| days | Bup+OTP | Bup+CHC | Counseling+OTP | Counseling+CHC |
|---|---|---|---|---|
| Criminal Activity | 3.4 ± 9.4 | 5.4 ± 11.4 | 3.3 ± 9.2 | 3.2 ± 9.0 |
Number of days employed during the past year
| days | B+OTP | B+CHC | C+OTP | C+CHC |
|---|---|---|---|---|
| Employment Status | 30.0 ± 28.1 | 29.6 ± 26.9 | 22.3 ± 32.4 | 31.4 ± 30.1 |
Number of times shared a needle during the past year
| times | B+OTP | B+CHC | C+OTP | C+CHC |
|---|---|---|---|---|
| HIV Risk Behavior Needle Sharing | 2.9 ± 15.9 | .1 ± .5 | 2.1 ± 13.6 | .1 ± 1.3 |
Number of times had sex without using a condom during the past year
| times | B+OTP | B+CHC | C+OTP | C+CHC |
|---|---|---|---|---|
| HIV Risk Behavior | 59.7 ± 52.6 | 36.1 ± 40.3 | 33.3 ± 29.3 | 50.4 ± 38.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| B+OTP | — | 4/52 (7.7%) | — |
| B+CHC | — | 14/52 (26.9%) | — |
| C+OTP | — | 10/54 (18.5%) | — |
| C+CHC | — | 10/53 (18.9%) | — |
| Event | B+OTP | B+CHC | C+OTP | C+CHC |
|---|---|---|---|---|
| pneumoniaInfections and infestations | 0/52 | 0/52 | 3/54 | 0/53 |
| unkownInvestigations | 1/52 | 2/52 | 0/54 | 1/53 |
| kidney problemInfections and infestations | 0/52 | 2/52 | 0/54 | 1/53 |
| suicidal ideationPsychiatric disorders | 0/52 | 0/52 | 2/54 | 2/53 |
| constipationGastrointestinal disorders | 1/52 | — | 0/54 | 0/53 |
| back injuryInjury, poisoning and procedural complications | 1/52 | 0/52 | 0/54 | 0/53 |
| swollen footInvestigations | 1/52 | 0/52 | 1/54 | 0/53 |
| depressionPsychiatric disorders | 0/52 | 1/52 | 0/54 | 0/53 |
| physical assualtInvestigations | 0/52 | 1/52 | 0/54 | 0/53 |
| blood clotBlood and lymphatic system disorders | 0/52 | 1/52 | 0/54 | 0/53 |
| Age, Continuous(years) | B+OTP | B+CHC | C+OTP | C+CHC | Total |
|---|---|---|---|---|---|
| Mean | 39.15 ± 7.5 | 39.18 ± 8.7 | 39.55 ± 10.0 | 38.42 ± 9.1 | 39.08 ± 8.8 |
| Sex: Female, Male(Participants) | B+OTP | B+CHC | C+OTP | C+CHC | Total |
|---|---|---|---|---|---|
| Female | 15 | 17 | 16 | 15 | 63 |
| Male | 37 | 35 | 38 | 38 | 148 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buprenorphine
Friends Research Institute, Inc.