Trial Outcomes & Findings for Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 (NCT NCT00142935)

NCT ID: NCT00142935

Last Updated: 2014-06-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: within 30 days post release of incarceration
• Results posted on: 2014-06-06

Participant Flow

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.

There were no significant events following participant enrollment and prior to group assignment.

Participant milestones

Measure	Pre-release MMT Initiation + Referral Post Release + Payment 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.	MMT Referral Post Release + Payment 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.	MMT Referral Post Release Participants assigned to this arm 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.
Overall Study STARTED	29	28	30
Overall Study COMPLETED	26	20	23
Overall Study NOT COMPLETED	3	8	7

Reasons for withdrawal

Measure	Pre-release MMT Initiation + Referral Post Release + Payment 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.	MMT Referral Post Release + Payment 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.	MMT Referral Post Release Participants assigned to this arm 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.
Overall Study Other reason	1	1	1
Overall Study Lost to Follow-up	2	5	5
Overall Study Death	0	2	1

Baseline Characteristics

Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1

Baseline characteristics by cohort

Measure	Pre-release MMT Initiation + Referral Post Release + Payment n=29 Participants Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.	MMT Referral Post Release + Payment n=28 Participants Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.	MMT Referral Post Release n=30 Participants Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	28 Participants n=7 Participants	30 Participants n=5 Participants	87 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	37.3 years STANDARD_DEVIATION 8.79 • n=5 Participants	37 years STANDARD_DEVIATION 6.69 • n=7 Participants	38.4 years STANDARD_DEVIATION 9.25 • n=5 Participants	37.6 years STANDARD_DEVIATION 8.27 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	60 Participants n=4 Participants
Region of Enrollment United States	29 participants n=5 Participants	28 participants n=7 Participants	30 participants n=5 Participants	87 participants n=4 Participants

PRIMARY outcome

Timeframe: within 30 days post release of incarceration

Population: We assessed community methadone treatment clinic attendance of all enrolled participants 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 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.

Outcome measures

Measure	As Assigned: Pre-release MMT + Referral Post Release + Payment n=29 Participants Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release + Payment n=28 Participants Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release n=30 Participants Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
Treatment Engagement	23 participants	11 participants	6 participants

PRIMARY outcome

Timeframe: within 30 days post release from incarceration

Population: Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis.

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.

Outcome measures

Measure	As Assigned: Pre-release MMT + Referral Post Release + Payment n=23 Participants Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release + Payment n=11 Participants Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release n=6 Participants Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
Time to MMT Initiation Post Release Based on Clinic Chart Review	2 days Standard Deviation 4.37	9 days Standard Deviation 9.74	5 days Standard Deviation 5.16

PRIMARY outcome

Timeframe: 6 month follow-up interviews

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.

Outcome measures

Measure	As Assigned: Pre-release MMT + Referral Post Release + Payment n=25 Participants Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release + Payment n=16 Participants Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release n=21 Participants Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
HIV Risk Behaviors - Self Report	3 participants	6 participants	8 participants

SECONDARY outcome

Timeframe: 6 month follow-up interviews

Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.

Outcome measures

Measure	As Assigned: Pre-release MMT + Referral Post Release + Payment n=25 Participants Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release + Payment n=16 Participants Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release n=21 Participants Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
Drug Use	6 participants	8 participants	11 participants

SECONDARY outcome

Timeframe: Within six months from release of incarceration

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.

Outcome measures

Measure	As Assigned: Pre-release MMT + Referral Post Release + Payment n=29 Participants Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release + Payment n=28 Participants Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release n=30 Participants Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
Fatal Overdose	0 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: 6 month follow-up interviews

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.

Outcome measures

Measure	As Assigned: Pre-release MMT + Referral Post Release + Payment n=25 Participants Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release + Payment n=16 Participants Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.	As Assigned: MMT Referral Post Release n=21 Participants Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
Non-fatal Overdose	3 participants	3 participants	2 participants

Adverse Events

As Assigned: Pre-release MMT + Referral Post Release + Payment

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

As Assigned: MMT Referral Post Release + Payment

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

As Assigned: MMT Referral Post Release

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	As Assigned: Pre-release MMT + Referral Post Release + Payment n=26 participants at risk；n=29 participants at risk Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews.	As Assigned: MMT Referral Post Release + Payment n=20 participants at risk；n=28 participants at risk Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews.	As Assigned: MMT Referral Post Release n=23 participants at risk；n=30 participants at risk Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance. Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews.
Injury, poisoning and procedural complications Fatal Overdose	0.00% 0/29 • 12 months Fatal Overdoses	7.1% 2/28 • Number of events 2 • 12 months Fatal Overdoses	3.3% 1/30 • Number of events 1 • 12 months Fatal Overdoses

Other adverse events

Measure	As Assigned: Pre-release MMT + Referral Post Release + Payment n=26 participants at risk；n=29 participants at risk Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews.	As Assigned: MMT Referral Post Release + Payment n=20 participants at risk；n=28 participants at risk Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews.	As Assigned: MMT Referral Post Release n=23 participants at risk；n=30 participants at risk Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance. Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews.
Injury, poisoning and procedural complications Non-fatal Overdose	11.5% 3/26 • Number of events 3 • 12 months Fatal Overdoses	15.0% 3/20 • Number of events 3 • 12 months Fatal Overdoses	8.7% 2/23 • Number of events 2 • 12 months Fatal Overdoses
Injury, poisoning and procedural complications ER visits	38.5% 10/26 • Number of events 10 • 12 months Fatal Overdoses	35.0% 7/20 • Number of events 7 • 12 months Fatal Overdoses	30.4% 7/23 • Number of events 7 • 12 months Fatal Overdoses
Injury, poisoning and procedural complications Hospitalizations	15.4% 4/26 • Number of events 4 • 12 months Fatal Overdoses	5.0% 1/20 • Number of events 1 • 12 months Fatal Overdoses	4.3% 1/23 • Number of events 1 • 12 months Fatal Overdoses

Additional Information

Josiah D. Rich, MD, MPH

The Miriam Hospital/Brown University

Phone: 401-793-4770

Email: jrich@lifespan.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place