An interventional study of Pre-release Initiation of MMT and Post Release Initiation of MMT. in HIV Prevention and Opioid-Related Disorders, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-06.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Prevention
Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to opiates. Many of these individuals pass through a correctional setting each year, creating an opportunity for linkage to substance abuse treatment. The purpose of this study was to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.
A substantial proportion of individuals addicted to heroin are incarcerated while addicted and a majority of individuals released from a correctional setting have a history of heroin addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV transmission and other problems, including drug relapse and overdose. Methadone treatment is the most widely used opiate replacement therapy in the United States and has been shown to decrease HIV risk, as well as drug use, addiction relapse, and criminal activity. The purpose of this study was to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.
Participants in this were randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 initiated methadone opiate replacement therapy about 1 month prior to release from incarceration. They proceeded with a methadone program of their choice upon release and received short-term payment to cover treatment costs. Participants enrolled in Group 2 were referred to a methadone program of their choice and received short-term payment to cover treatment costs. Participants enrolled in Group 3 were referred to a program of choice upon release from incarceration without receiving financial assistance. All participants had the opportunity to partake in existing support programs available at the Rhode Island Department of Corrections while incarcerated and in the community upon release. Follow-up assessments occurred at Months 1.5, 6, and 12. These included interviews and urine specimens for toxicology analysis to verify self-reports.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 87 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
Behavioral: Pre-release Initiation of MMT
Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
Behavioral: Post Release Initiation of MMT.
Participants assigned to this arem will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
Behavioral: Standard of Care Plus
Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
Treatment Engagement
Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.
Time frame: within 30 days post release of incarceration
Time to MMT Initiation Post Release Based on Clinic Chart Review
Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.
Time frame: within 30 days post release from incarceration
HIV Risk Behaviors - Self Report
Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.
Time frame: 6 month follow-up interviews
Drug Use
Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.
Time frame: 6 month follow-up interviews
Fatal Overdose
Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.
Time frame: Within six months from release of incarceration
Non-fatal Overdose
Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.
Time frame: 6 month follow-up interviews
All recruitment occurred at the Rhode Island Department of Corrections. Screening began on 9/15/2006 and the first participant was enrolled on 9/29/2006. The last participant was enrolled on 2/20/2009.
| Milestone | Pre-release MMT Initiation + Referral Post Release + Payment | MMT Referral Post Release + Payment | MMT Referral Post Release |
|---|---|---|---|
| Started | 29 | 28 | 30 |
| Completed | 26 | 20 | 23 |
| Not completed | 3 | 8 | 7 |
| Withdrew: Other reason | 1 | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 5 | 5 |
| Withdrew: Death | 0 | 2 | 1 |
Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.
| participants | As Assigned: Pre-release MMT + Referral Post Release + Payment | As Assigned: MMT Referral Post Release + Payment | As Assigned: MMT Referral Post Release |
|---|---|---|---|
| Treatment Engagement | 23 | 11 | 6 |
Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.
| days | As Assigned: Pre-release MMT + Referral Post Release + Payment | As Assigned: MMT Referral Post Release + Payment | As Assigned: MMT Referral Post Release |
|---|---|---|---|
| Time to MMT Initiation Post Release Based on Clinic Chart Review | 2 ± 4.37 | 9 ± 9.74 | 5 ± 5.16 |
Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.
| participants | As Assigned: Pre-release MMT + Referral Post Release + Payment | As Assigned: MMT Referral Post Release + Payment | As Assigned: MMT Referral Post Release |
|---|---|---|---|
| HIV Risk Behaviors - Self Report | 3 | 6 | 8 |
Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.
| participants | As Assigned: MMT Pre-release + Referral Post Release + Payment | As Assigned: MMT Referral Post Release + Payment | As Assigned: MMT Referral Post Release |
|---|---|---|---|
| Drug Use | 6 | 8 | 11 |
Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.
| participants | As Assigned: MMT Pre-release + Referral Post Release + Payment | As Assigned: MMT Referral Post Release + Payment | As Assigned: MMT Referral Post Release |
|---|---|---|---|
| Fatal Overdose | 0 | 1 | 1 |
Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.
| participants | As Assigned: MMT Pre-release + Referral Post Release + Payment | As Assigned: MMT Referral Post Release + Payment | As Assigned: MMT Referral Post Release |
|---|---|---|---|
| Non-fatal Overdose | 3 | 3 | 2 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| As Assigned: Pre-release MMT + Referral Post Release + Payment | — | 0/29 (0%) | 10/26 (38.5%) |
| As Assigned: MMT Referral Post Release + Payment | — | 2/28 (7.1%) | 8/20 (40%) |
| As Assigned: MMT Referral Post Release | — | 1/30 (3.3%) | 8/23 (34.8%) |
| Event | As Assigned: Pre-release MMT + Referral Post Release + Payment | As Assigned: MMT Referral Post Release + Payment | As Assigned: MMT Referral Post Release |
|---|---|---|---|
| Fatal OverdoseInjury, poisoning and procedural complications | 0/29 | 2/28 | 1/30 |
| Event | As Assigned: Pre-release MMT + Referral Post Release + Payment | As Assigned: MMT Referral Post Release + Payment | As Assigned: MMT Referral Post Release |
|---|---|---|---|
| ER visitsInjury, poisoning and procedural complications | 10/26 | 7/20 | 7/23 |
| HospitalizationsInjury, poisoning and procedural complications | 4/26 | 1/20 | 1/23 |
| Non-fatal OverdoseInjury, poisoning and procedural complications | 3/26 | 3/20 | 2/23 |
| Age, Categorical(Participants) | Pre-release MMT Initiation + Referral Post Release + Payment | MMT Referral Post Release + Payment | MMT Referral Post Release | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 28 | 30 | 87 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Pre-release MMT Initiation + Referral Post Release + Payment | MMT Referral Post Release + Payment | MMT Referral Post Release | Total |
|---|---|---|---|---|
| Mean | 37.3 ± 8.79 | 37 ± 6.69 | 38.4 ± 9.25 | 37.6 ± 8.27 |
| Sex: Female, Male(Participants) | Pre-release MMT Initiation + Referral Post Release + Payment | MMT Referral Post Release + Payment | MMT Referral Post Release | Total |
|---|---|---|---|---|
| Female | 10 | 8 | 9 | 27 |
| Male | 19 | 20 | 21 | 60 |
| Region of Enrollment(participants) | Pre-release MMT Initiation + Referral Post Release + Payment | MMT Referral Post Release + Payment | MMT Referral Post Release | Total |
|---|---|---|---|---|
| United States | 29 | 28 | 30 | 87 |
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