Heroin Addiction
Conditions
Brief summary
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
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.
Interventions
OTHERCounseling Only
Counseling only in prison, with passive referral to drug abuse treatment upon release
DRUGCounseling + Transfer
Counseling only in prison, with opportunity to enter methadone maintenance upon release
DRUGCounseling + Methadone
Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
Sponsors
National Institute on Drug Abuse (NIDA)
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Pending parole hearing * Pending charges * Kidney failure * Liver failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Retention in the Community | one year post prison release | days in community treatment |
| Heroin Use | results at one year post prison release | opioid urine test results-percent of participants who were opioid-positive |
| Cocaine Use | one year post prison release | cocaine urine test results-percent of participants testing positive for cocaine |
| HIV-risk Behaviors | one year | — |
| Criminal Activity | one year post prison release | self reported days of criminal activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Employment | one year | number of days employed, past 30 days-self report, assessed one year post-prison release |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
See above
Participants by arm
| Arm | Count |
|---|---|
| 1 Counseling Only in Prison Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release | 70 |
| 2 Counseling Only in Prison, With Initiation of Methadone Main Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release | 70 |
| 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 | 71 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 1 | 0 |
Baseline characteristics
| Characteristic | 2 Counseling Only in Prison, With Initiation of Methadone Main | 3 Counseling and Methadone Maintenance in Prison, With Continu | 1 Counseling Only in Prison | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 71 Participants | 70 Participants | 211 Participants |
| Age, Continuous | 40.3 years STANDARD_DEVIATION 6.7 | 39.9 years STANDARD_DEVIATION 7 | 40.7 years STANDARD_DEVIATION 7.5 | 40.3 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 70 participants | 71 participants | 70 participants | 211 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 70 Participants | 71 Participants | 70 Participants | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 15 / 70 | 6 / 70 | 16 / 71 |
Outcome results
Primary
Cocaine Use
cocaine urine test results-percent of participants testing positive for cocaine
Time frame: one year post prison release
Population: Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due, excludes those assessed later or reincarcerated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Counseling Only in Prison | Cocaine Use | 71.9 percent cocaine positive participants |
| 2 Counseling Only in Prison, With Initiation of Methadone Main | Cocaine Use | 66.6 percent cocaine positive participants |
| 3 Counseling and Methadone Maintenance in Prison, With Continu | Cocaine Use | 43.2 percent cocaine positive participants |
Primary
Criminal Activity
self reported days of criminal activity
Time frame: one year post prison release
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Counseling Only in Prison | Criminal Activity | 106.7 number of days | Standard Deviation 128.7 |
| 2 Counseling Only in Prison, With Initiation of Methadone Main | Criminal Activity | 65.2 number of days | Standard Deviation 96.2 |
| 3 Counseling and Methadone Maintenance in Prison, With Continu | Criminal Activity | 81.8 number of days | Standard Deviation 109.5 |
Primary
Heroin Use
opioid urine test results-percent of participants who were opioid-positive
Time frame: results at one year post prison release
Population: Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due-excludes those assessed later or reincarcerated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Counseling Only in Prison | Heroin Use | 65.6 % participants opioid positive |
| 2 Counseling Only in Prison, With Initiation of Methadone Main | Heroin Use | 48.7 % participants opioid positive |
| 3 Counseling and Methadone Maintenance in Prison, With Continu | Heroin Use | 25.0 % participants opioid positive |
Primary
HIV-risk Behaviors
Time frame: one year
Primary
Treatment Retention in the Community
days in community treatment
Time frame: one year post prison release
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Counseling Only in Prison | Treatment Retention in the Community | 23.1 Days in community treatment | Standard Deviation 72.5 |
| 2 Counseling Only in Prison, With Initiation of Methadone Main | Treatment Retention in the Community | 91.3 Days in community treatment | Standard Deviation 144.6 |
| 3 Counseling and Methadone Maintenance in Prison, With Continu | Treatment Retention in the Community | 166.0 Days in community treatment | Standard Deviation 166.4 |
Secondary
Employment
number of days employed, past 30 days-self report, assessed one year post-prison release
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Counseling Only in Prison | Employment | 12.0 number of days employed, past 30 | Standard Deviation 10.3 |
| 2 Counseling Only in Prison, With Initiation of Methadone Main | Employment | 10.3 number of days employed, past 30 | Standard Deviation 10.9 |
| 3 Counseling and Methadone Maintenance in Prison, With Continu | Employment | 8.5 number of days employed, past 30 | Standard Deviation 10.5 |