Trial Outcomes & Findings for Methadone Maintenance for Prisoners (NCT NCT00378079)
NCT ID: NCT00378079
Last Updated: 2014-04-03
Results Overview
days in community treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
211 participants
Primary outcome timeframe
one year post prison release
Results posted on
2014-04-03
Participant Flow
See publication in Journal of Substance Abuse Treatment (2009), 37, 277-285.In summary, participants were recruited between September 2003 and June 2005 from male prisoners in a Baltimore pre-release facility. They had to have met criteria for methadone maintenance treatment in the year prior to incarceration.
See above
Participant milestones
| Measure |
1 Counseling Only in Prison
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
71
|
|
Overall Study
COMPLETED
|
64
|
69
|
71
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
0
|
Reasons for withdrawal
| Measure |
1 Counseling Only in Prison
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
0
|
Baseline Characteristics
Methadone Maintenance for Prisoners
Baseline characteristics by cohort
| Measure |
1 Counseling Only in Prison
n=70 Participants
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
n=70 Participants
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
n=71 Participants
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
Total
n=211 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
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
211 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
|
40.7 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
39.9 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
70 participants
n=7 Participants
|
71 participants
n=5 Participants
|
211 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one year post prison releasedays in community treatment
Outcome measures
| Measure |
1 Counseling Only in Prison
n=64 Participants
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
n=69 Participants
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
n=71 Participants
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
|---|---|---|---|
|
Treatment Retention in the Community
|
23.1 Days in community treatment
Standard Deviation 72.5
|
91.3 Days in community treatment
Standard Deviation 144.6
|
166.0 Days in community treatment
Standard Deviation 166.4
|
PRIMARY outcome
Timeframe: results at one year post prison releasePopulation: Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due-excludes those assessed later or reincarcerated
opioid urine test results-percent of participants who were opioid-positive
Outcome measures
| Measure |
1 Counseling Only in Prison
n=32 Participants
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
n=39 Participants
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
n=44 Participants
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
|---|---|---|---|
|
Heroin Use
|
65.6 % participants opioid positive
|
48.7 % participants opioid positive
|
25.0 % participants opioid positive
|
PRIMARY outcome
Timeframe: one year post prison releasePopulation: Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due, excludes those assessed later or reincarcerated
cocaine urine test results-percent of participants testing positive for cocaine
Outcome measures
| Measure |
1 Counseling Only in Prison
n=32 Participants
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
n=39 Participants
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
n=44 Participants
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
|---|---|---|---|
|
Cocaine Use
|
71.9 percent cocaine positive participants
|
66.6 percent cocaine positive participants
|
43.2 percent cocaine positive participants
|
PRIMARY outcome
Timeframe: one yearOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: one year post prison releaseself reported days of criminal activity
Outcome measures
| Measure |
1 Counseling Only in Prison
n=64 Participants
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
n=69 Participants
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
n=71 Participants
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
|---|---|---|---|
|
Criminal Activity
|
106.7 number of days
Standard Deviation 128.7
|
65.2 number of days
Standard Deviation 96.2
|
81.8 number of days
Standard Deviation 109.5
|
SECONDARY outcome
Timeframe: one yearnumber of days employed, past 30 days-self report, assessed one year post-prison release
Outcome measures
| Measure |
1 Counseling Only in Prison
n=64 Participants
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
n=69 Participants
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
n=71 Participants
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
|---|---|---|---|
|
Employment
|
12.0 number of days employed, past 30
Standard Deviation 10.3
|
10.3 number of days employed, past 30
Standard Deviation 10.9
|
8.5 number of days employed, past 30
Standard Deviation 10.5
|
Adverse Events
1 Counseling Only in Prison
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Counseling Only in Prison, With Initiation of Methadone Main
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Counseling and Methadone Maintenance in Prison, With Continu
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Counseling Only in Prison
n=70 participants at risk
Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
|
2 Counseling Only in Prison, With Initiation of Methadone Main
n=70 participants at risk
Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
|
3 Counseling and Methadone Maintenance in Prison, With Continu
n=71 participants at risk
Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Death
|
8.6%
6/70 • Number of events 6 • at any time up to one year after release from prison
The first series of results reports the number and percent of participants by treatment condition who died. The second series involve hospitalizations-the number of participants in each condition that had one or more hospitalizations and the number of events. Other (non-serious) Adverse Events were not collected/assessed..
|
1.4%
1/70 • Number of events 1 • at any time up to one year after release from prison
The first series of results reports the number and percent of participants by treatment condition who died. The second series involve hospitalizations-the number of participants in each condition that had one or more hospitalizations and the number of events. Other (non-serious) Adverse Events were not collected/assessed..
|
1.4%
1/71 • Number of events 1 • at any time up to one year after release from prison
The first series of results reports the number and percent of participants by treatment condition who died. The second series involve hospitalizations-the number of participants in each condition that had one or more hospitalizations and the number of events. Other (non-serious) Adverse Events were not collected/assessed..
|
|
General disorders
hospitalizations
|
12.9%
9/70 • Number of events 9 • at any time up to one year after release from prison
The first series of results reports the number and percent of participants by treatment condition who died. The second series involve hospitalizations-the number of participants in each condition that had one or more hospitalizations and the number of events. Other (non-serious) Adverse Events were not collected/assessed..
|
7.1%
5/70 • Number of events 14 • at any time up to one year after release from prison
The first series of results reports the number and percent of participants by treatment condition who died. The second series involve hospitalizations-the number of participants in each condition that had one or more hospitalizations and the number of events. Other (non-serious) Adverse Events were not collected/assessed..
|
21.1%
15/71 • Number of events 20 • at any time up to one year after release from prison
The first series of results reports the number and percent of participants by treatment condition who died. The second series involve hospitalizations-the number of participants in each condition that had one or more hospitalizations and the number of events. Other (non-serious) Adverse Events were not collected/assessed..
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place