Heroin AddictionPhase 3MMPNCT00378079

Methadone Maintenance for Prisoners

A Phase 3 study testing Counseling Only, Counseling + Transfer and Counseling + Methadone in people with Heroin Addiction, run by Friends Research Institute, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Heroin Addiction
What is being tested?: Counseling Only, Counseling + Transfer and Counseling + Methadone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 211 participants
Where: 1 siteUnited States
Study dates: Sep 2003to Jan 2008
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 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Heroin dependence in the year prior to current incarceration
3-6 months left to serve in prison-male pre-release inmate suitability for methadone maintenance as determined by medical evaluation
Willingness to enroll in methadone maintenance
Having a Baltimore address

Who cannot join

Pending parole hearing
Pending charges
Kidney failure
Liver failure

Trial locations and contacts

1 site in 1 country.

United States1 site

Metropolitan Transition Center
Baltimore, Maryland, 21201

Other trials in United States

About this study

This five-year study examines the benefits of methadone maintenance treatment initiated in prison and continued in the community to male offenders who were previously, but not currently, heroin-dependent. It is anticipated that such prisoners will have more favorable outcomes in the year following release with regard to drug abuse, crime, and HIV risk behavior than either prisoners who receive counseling only or begin initiation of methadone maintenance in the community

Read the detailed description

Most prisoners with histories of pre-incarceration heroin addiction do not receive treatment while incarcerated or upon release. Effective treatment for such prisoners is urgently needed because rapid relapse typically follows release. Relapse is associated with increased risk for HIV, overdose death, criminal activity, and reincarceration. Other than three studies of methadone maintenance with short-term jail inmates, the only study of longer-term inmates who were previously, but not currently, heroin-dependent was the investigator's pilot study with pre-release inmates. Based on that pilot study, which found that initiating maintenance treatment is feasible and facilitates post-release treatment entry, the present study provides a more rigorous examination of this unique treatment approach.

Conditions: Heroin Addiction
Being tested: Counseling Only, Counseling + Transfer, Counseling + Methadone
Medical subject headings: Heroin Dependence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Counseling OnlyOther
Counseling only in prison, with passive referral to drug abuse treatment upon release
Counseling + TransferDrug
Counseling only in prison, with opportunity to enter methadone maintenance upon release
Counseling + MethadoneDrug
Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release

Study groups in NCT00378079
Study group	Role	What they receive
3	Experimental	Not described Receives: Drug: Counseling + Methadone
1	Active comparator	Not described Receives: Other: Counseling Only
2	Experimental	Not described Receives: Drug: Counseling + Transfer

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Retention in the Community
days in community treatment
Measured: one year post prison release
Heroin Use
opioid urine test results-percent of participants who were opioid-positive
Measured: results at one year post prison release
Cocaine Use
cocaine urine test results-percent of participants testing positive for cocaine
Measured: one year post prison release
HIV-risk Behaviors
Measured: one year
Criminal Activity
self reported days of criminal activity
Measured: one year post prison release

Secondary outcomes (1)

Employment
number of days employed, past 30 days-self report, assessed one year post-prison release
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2003Jan 2008

First posted19 Sep 2006 (estimated)
Study startSep 2003
Primary completionJan 2008
Study completionJan 2008

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 (7)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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00378079
Sponsor's protocol ID: 1R01DA016237-03
Other IDs: R01DA016237
Acronym: MMP
Status last verified: Apr 2014
First submitted: 15 Sep 2006
Last updated: 3 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kinlock TW, Schwartz RP, Gordon MS. The significance of interagency collaboration in developing opioid agonist programs for inmates. Corrections Compendium 30(3)6-9,28-30,2005.
Kinlock TW, Gordon MS, Schwartz RP, O'Grady K, Fitzgerald TT, Wilson M. A randomized clinical trial of methadone maintenance for prisoners: results at 1-month post-release. Drug Alcohol Depend. 2007 Dec 1;91(2-3):220-7. doi: 10.1016/j.drugalcdep.2007.05.022. Epub 2007 Jul 12.
PubMed 17628351
Kinlock TW, Gordon MS, Schwartz RP, O'Grady KE. A Study of Methadone Maintenance For Male Prisoners: 3-Month Postrelease Outcomes. Crim Justice Behav. 2008;35(1):34-47. doi: 10.1177/0093854807309111.
PubMed 18612373
Gordon MS, Kinlock TW, Schwartz RP, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release. Addiction. 2008 Aug;103(8):1333-42. doi: 10.1111/j.1360-0443.2008.002238.x.
PubMed 18855822
Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: results at 12 months postrelease. J Subst Abuse Treat. 2009 Oct;37(3):277-85. doi: 10.1016/j.jsat.2009.03.002. Epub 2009 Mar 31.
PubMed 19339140
Wilson ME, Kinlock TW, Gordon MS, O'Grady KE, Schwartz RP. Postprison release HIV-risk behaviors in a randomized trial of methadone treatment for prisoners. Am J Addict. 2012 Sep-Oct;21(5):476-87. doi: 10.1111/j.1521-0391.2012.00250.x.
PubMed 22882399
Kinlock TW, Gordon MS, Schwartz RP, O'Grady KE. Individual Patient and Program Factors Related to Prison and Community Treatment Completion in Prison-Initiated Methadone Maintenance Treatment. J Offender Rehabil. 2013 Oct;52(8):509-528. doi: 10.1080/10509674.2013.782936.
PubMed 25580067

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Methadone Maintenance for Prisoners
ClinicalTrials.gov ID: NCT00378079
Acronym / sponsor ID: MMP / 1R01DA016237-03
Conditions: Heroin Addiction
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: Friends Research Institute, Inc.University, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Sep 2003
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 19 Sep 2006 (estimated)
Results: Posted 3 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
3	Experimental	Drug: Counseling + Methadone
1	Active comparator	Other: Counseling Only
2	Experimental	Drug: Counseling + Transfer

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Heroin dependence in the year prior to current incarceration
3-6 months left to serve in prison-male pre-release inmate suitability for methadone maintenance as determined by medical evaluation
Willingness to enroll in methadone maintenance
Having a Baltimore address

Key exclusion criteria (4 listed)

Pending parole hearing
Pending charges
Kidney failure
Liver failure

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
Counseling OnlyCounseling only in prison, with passive referral to drug abuse treatment upon release	Other	1
Counseling + TransferCounseling only in prison, with opportunity to enter methadone maintenance upon release	Drug	2
Counseling + MethadoneCounseling and methadone maintenance in prison, with opportunity to continue that treatment upon release	Drug	3

Primary outcome

Treatment Retention in the Community
Time frame: one year post prison release
days in community treatment
Heroin Use
Time frame: results at one year post prison release
opioid urine test results-percent of participants who were opioid-positive
Cocaine Use
Time frame: one year post prison release
cocaine urine test results-percent of participants testing positive for cocaine
HIV-risk Behaviors
Time frame: one year
Criminal Activity
Time frame: one year post prison release
self reported days of criminal activity

1 secondary outcome

Employment
Time frame: one year

Results and safety

Results posted to the registry on 3 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Counseling Only in Prison	70	64
2 Counseling Only in Prison, With Initiation of Methadone Main	70	69
3 Counseling and Methadone Maintenance in Prison, With Continu	71	71

Primary outcome: Treatment Retention in the Community

Time frame: one year post prison release. Mean (Standard Deviation). Unit: Days in community treatment

Measure	1 Counseling Only in Prison n = 64	2 Counseling Only in Prison, With Initiation of Methadone Main n = 69	3 Counseling and Methadone Maintenance in Prison, With Continu n = 71
Value	23.1 (72.5)	91.3 (144.6)	166.0 (166.4)

Primary outcome: Heroin Use

Time frame: results at one year post prison release. Number. Unit: % participants opioid positive

Measure	1 Counseling Only in Prison n = 32	2 Counseling Only in Prison, With Initiation of Methadone Main n = 39	3 Counseling and Methadone Maintenance in Prison, With Continu n = 44
Value	65.6	48.7	25.0

Population analysed: Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due-excludes those assessed later or reincarcerated

Primary outcome: Cocaine Use

Time frame: one year post prison release. Number. Unit: percent cocaine positive participants

Measure	1 Counseling Only in Prison n = 32	2 Counseling Only in Prison, With Initiation of Methadone Main n = 39	3 Counseling and Methadone Maintenance in Prison, With Continu n = 44
Value	71.9	66.6	43.2

Population analysed: Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due, excludes those assessed later or reincarcerated

Primary outcome: HIV-risk Behaviors

Time frame: one year

The sponsor has not posted figures for this outcome.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: at any time up to one year after release from prison. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Counseling Only in Prison	15 of 70 (21.4%)	0 of 0	Not reported
2 Counseling Only in Prison, With Initiation of Methadone Main	6 of 70 (8.6%)	0 of 0	Not reported
3 Counseling and Methadone Maintenance in Prison, With Continu	16 of 71 (22.5%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): See 2009 manuscript published in the Journal of Substance Abuse Treatment for the a discussion of study limitations. The study was conducted only on males from Baltimore. For results regarding HIV risk behaviors see manuscript by Wilson et. al.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundKinlock TW, Schwartz RP, Gordon MS. The significance of interagency collaboration in developing opioid agonist programs for inmates. Corrections Compendium 30(3)6-9,28-30,2005.
Results publication: PubMed 17628351Kinlock TW, Gordon MS, Schwartz RP, O'Grady K, Fitzgerald TT, Wilson M. A randomized clinical trial of methadone maintenance for prisoners: results at 1-month post-release. Drug Alcohol Depend. 2007 Dec 1;91(2-3):220-7. doi: 10.1016/j.drugalcdep.2007.05.022. Epub 2007 Jul 12.
Results publication: PubMed 18612373Kinlock TW, Gordon MS, Schwartz RP, O'Grady KE. A Study of Methadone Maintenance For Male Prisoners: 3-Month Postrelease Outcomes. Crim Justice Behav. 2008;35(1):34-47. doi: 10.1177/0093854807309111.
Results publication: PubMed 18855822Gordon MS, Kinlock TW, Schwartz RP, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release. Addiction. 2008 Aug;103(8):1333-42. doi: 10.1111/j.1360-0443.2008.002238.x.
Results publication: PubMed 19339140Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: results at 12 months postrelease. J Subst Abuse Treat. 2009 Oct;37(3):277-85. doi: 10.1016/j.jsat.2009.03.002. Epub 2009 Mar 31.
Results publication: PubMed 22882399Wilson ME, Kinlock TW, Gordon MS, O'Grady KE, Schwartz RP. Postprison release HIV-risk behaviors in a randomized trial of methadone treatment for prisoners. Am J Addict. 2012 Sep-Oct;21(5):476-87. doi: 10.1111/j.1521-0391.2012.00250.x.
Results publication: PubMed 25580067Kinlock TW, Gordon MS, Schwartz RP, O'Grady KE. Individual Patient and Program Factors Related to Prison and Community Treatment Completion in Prison-Initiated Methadone Maintenance Treatment. J Offender Rehabil. 2013 Oct;52(8):509-528. doi: 10.1080/10509674.2013.782936.

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.

Timothy W Kinlock, Ph.D. principal investigator

Friends Research Institute, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Counseling Only, Counseling + Transfer and Counseling + Methadone in people with Heroin Addiction, run by Friends Research Institute, Inc. at 1 site 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 4 inclusion and 4 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 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 Apr 2014). 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?

Treatment Retention in the Community (time frame: one year post prison release). The study lists 5 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 NCT00378079, which also lists 7 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 3 Apr 2014; AzTrials last refreshed its copy on 27 Oct 2026.