Heroin AddictionPhase 3NCT00574067
Buprenorphine for Prisoners
A Phase 3 study testing Buprenorphine +OTP, Buprenorphine +CHC and Counseling +OTP in people with Heroin Addiction, run by Friends Research Institute, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heroin Addiction
- What is being tested?
- Buprenorphine +OTP, Buprenorphine +CHC and Counseling +OTP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- pre-release prison inmate with 3-6 months remaining until planned release
- history of heroin dependence(meeting DSM-IV criteria of heroin dependence at the time of incarceration and manifesting physical dependence during the year preceding incarceration
- suitability for buprenorphine treatment as determined by medical evaluation
- willingness to participate in the study
- having a Baltimore address and planning to live in Baltimore after release from prison -
Who cannot join
- evidence of kidney failure
- evidence of liver failure
- history of psychosis
- having a pending parole hearing
- unadjudicated charges that could result in additional prison time or transfer to another facility -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Metropolitan Transition Center
Baltimore, Maryland, 21201
Maryland Correctional Institution for Women
Jessup, Maryland, 20794
About this study
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.
Read the detailed description
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.
- Conditions
- Heroin Addiction
- Being tested
- Buprenorphine +OTP, Buprenorphine +CHC, Counseling +OTP, Counseling +CHC
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine +OTPDrug
Also called Suboxone
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
Buprenorphine +CHCDrug
Also called Suboxone
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.
Counseling +OTPDrug
Also called Suboxone
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.
Counseling +CHCDrug
Also called Suboxone
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.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine+OTP | Experimental | Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release. Receives: Drug: Buprenorphine +OTP |
| Buprenorphine+CHC | Experimental | Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release. Receives: Drug: Buprenorphine +CHC |
| Counseling + OTP | Active comparator | Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP) Receives: Drug: Counseling +OTP |
| Counseling + CHC | Active comparator | Counseling only in prisons and Buprenorphine upon release at a community health center (CHC) Receives: Drug: Counseling +CHC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days of Heroin Use
mean days used heroin during the past 30 days
Measured: 1 year
Drug Abuse Treatment Entry and Retention in the Community
entered community treatment within 10 days of release from prison (yes vs. no)
Measured: 1 year
Secondary outcomes (5)
Number of Days of Cocaine Use
Number of days used cocaine during the past 30 days.
Measured: 1 year
Criminal Activity
Days of crime during the past 30 days
Measured: 1 year
Employment Status
Number of days employed during the past year
Measured: 1 year
HIV Risk Behavior Needle Sharing
Number of times shared a needle during the past year
Measured: 1 year
HIV Risk Behavior
Number of times had sex without using a condom during the past year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startSep 2008
- Primary completionMar 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heroin AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574067
- Sponsor's protocol ID
- 1R01DA021579-01A1
- Other IDs
- R01DA021579, 1R01DA021579-01A1
- Status last verified
- Jul 2018
- First submitted
- 12 Dec 2007
- Last updated
- 29 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT. Developing and Implementing a New Prison-Based Buprenorphine Treatment Program. J Offender Rehabil. 2010 Feb;49(2):91-109. doi: 10.1080/10509670903534951.
PubMed 20473351Gordon MS, Kinlock TW, Schwartz RP, Couvillion KA, O'Grady KE. The Severity, Frequency, and Variety of Crime in Heroin-Dependent Prisoners Enrolled in a Buprenorphine Clinical Trial. Prison J. 2013 Dec 1;93(4):390-410. doi: 10.1177/0032885513500753.
PubMed 25392564Blue TR, Gordon MS, Schwartz RP, Couvillion K, Vocci FJ, Fitzgerald TT, O'Grady KE. Longitudinal analysis of HIV-risk behaviors of participants in a randomized trial of prison-initiated buprenorphine. Addict Sci Clin Pract. 2019 Dec 2;14(1):45. doi: 10.1186/s13722-019-0172-2.
PubMed 31787108
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine for Prisoners
- ClinicalTrials.gov ID
- NCT00574067
- Acronym / sponsor ID
- 1R01DA021579-01A1
- Conditions
- Heroin Addiction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 11 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine+OTP | Experimental | Drug: Buprenorphine +OTPBuprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release. |
| Buprenorphine+CHC | Experimental | Drug: Buprenorphine +CHCBuprenorphine and counseling in prison and continued at a community health center (CHC) upon release. |
| Counseling + OTP | Active comparator | Drug: Counseling +OTPCounseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP) |
| Counseling + CHC | Active comparator | Drug: Counseling +CHCCounseling only in prisons and Buprenorphine upon release at a community health center (CHC) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pre-release prison inmate with 3-6 months remaining until planned release
- history of heroin dependence(meeting DSM-IV criteria of heroin dependence at the time of incarceration and manifesting physical dependence during the year preceding incarceration
- suitability for buprenorphine treatment as determined by medical evaluation
- willingness to participate in the study
- having a Baltimore address and planning to live in Baltimore after release from prison -
Key exclusion criteria (5 listed)
- evidence of kidney failure
- evidence of liver failure
- history of psychosis
- having a pending parole hearing
- unadjudicated charges that could result in additional prison time or transfer to another facility -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine +OTPAlso: SuboxoneBuprenorphine 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 | Drug | Buprenorphine+OTP |
| Buprenorphine +CHCAlso: SuboxoneBuprenorphine 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. | Drug | Buprenorphine+CHC |
| Counseling +OTPAlso: SuboxoneCounseling 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. | Drug | Counseling + OTP |
| Counseling +CHCAlso: SuboxoneCounseling 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. | Drug | Counseling + CHC |
Primary outcome
Number of Days of Heroin Use
Time frame: 1 year
mean days used heroin during the past 30 days
Drug Abuse Treatment Entry and Retention in the Community
Time frame: 1 year
entered community treatment within 10 days of release from prison (yes vs. no)
5 secondary outcomes
Number of Days of Cocaine Use
Time frame: 1 year
Criminal Activity
Time frame: 1 year
Employment Status
Time frame: 1 year
HIV Risk Behavior Needle Sharing
Time frame: 1 year
HIV Risk Behavior
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20473351Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT. Developing and Implementing a New Prison-Based Buprenorphine Treatment Program. J Offender Rehabil. 2010 Feb;49(2):91-109. doi: 10.1080/10509670903534951.
- Background: PubMed 25392564Gordon MS, Kinlock TW, Schwartz RP, Couvillion KA, O'Grady KE. The Severity, Frequency, and Variety of Crime in Heroin-Dependent Prisoners Enrolled in a Buprenorphine Clinical Trial. Prison J. 2013 Dec 1;93(4):390-410. doi: 10.1177/0032885513500753.
- Derived from this study: PubMed 31787108Blue TR, Gordon MS, Schwartz RP, Couvillion K, Vocci FJ, Fitzgerald TT, O'Grady KE. Longitudinal analysis of HIV-risk behaviors of participants in a randomized trial of prison-initiated buprenorphine. Addict Sci Clin Pract. 2019 Dec 2;14(1):45. doi: 10.1186/s13722-019-0172-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine +OTP, Buprenorphine +CHC and Counseling +OTP in people with Heroin Addiction, run by Friends Research Institute, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days of Heroin Use (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00574067, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.