Heroin Addiction
Conditions
Brief summary
This five-year study examines the effectiveness of buprenorphine treatment provided to previously-addicted inmates(N=320; 160 males, 160 females) initiated in prison and continued in the community. The study also examines the extent to which the setting of post-release buprenorphine is provided.It is expected that participants receiving in-prison buprenorphine will have superior outcomes compared to participants who did not receive in-prison buprenorphine.
Detailed description
Participants will be randomly assigned, within gender, to one of four treatment conditions: 1) buprenorphine and counseling in prison, with referral for continued treatment at an OTP upon release; 2) buprenorphine and counseling in prison, with referral for continued treatment at a CHC upon release; 3) counseling only in prison, with referral for buprenorphine and counseling at a OTP upon release; and 4) counseling only in prison, with referral for buprenorphine and counseling at a CHC upon release. Participants will be assessed at study entry and at 1, 3, 6, and 12 months following their release from prison. Outcome measures include: treatment entry and retention in the community, heroin use, cocaine use, HIV infection, HIV-risk behaviors, criminal activity, and employment.
Interventions
DRUGBuprenorphine +OTP
Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment (OTP) program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
DRUGBuprenorphine +CHC
Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center (CHC). Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
DRUGCounseling +OTP
Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
DRUGCounseling +CHC
Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
Sponsors
National Institute on Drug Abuse (NIDA)
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. pre-release prison inmate with 3-6 months remaining until planned release 2. history of heroin dependence(meeting DSM-IV criteria of heroin dependence at the time of incarceration and manifesting physical dependence during the year preceding incarceration 3. suitability for buprenorphine treatment as determined by medical evaluation 4. willingness to participate in the study 5. having a Baltimore address and planning to live in Baltimore after release from prison -
Exclusion criteria
1. evidence of kidney failure 2. evidence of liver failure 3. history of psychosis 4. having a pending parole hearing 5. unadjudicated charges that could result in additional prison time or transfer to another facility -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days of Heroin Use | 1 year | mean days used heroin during the past 30 days |
| Drug Abuse Treatment Entry and Retention in the Community | 1 year | entered community treatment within 10 days of release from prison (yes vs. no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Employment Status | 1 year | Number of days employed during the past year |
| Number of Days of Cocaine Use | 1 year | Number of days used cocaine during the past 30 days. |
| HIV Risk Behavior | 1 year | Number of times had sex without using a condom during the past year |
| HIV Risk Behavior Needle Sharing | 1 year | Number of times shared a needle during the past year |
| Criminal Activity | 1 year | Days of crime during the past 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| B+OTP Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays | 52 |
| B+CHC Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays. | 52 |
| C+OTP Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays. | 54 |
| C+CHC Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays. | 53 |
| Total | 211 |
Baseline characteristics
| Characteristic | B+OTP | B+CHC | C+OTP | C+CHC | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.15 years STANDARD_DEVIATION 7.5 | 39.18 years STANDARD_DEVIATION 8.7 | 39.55 years STANDARD_DEVIATION 10 | 38.42 years STANDARD_DEVIATION 9.1 | 39.08 years STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 16 Participants | 15 Participants | 63 Participants |
| Sex: Female, Male Male | 37 Participants | 35 Participants | 38 Participants | 38 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 4 / 52 | 14 / 52 | 10 / 54 | 10 / 53 |
Outcome results
Primary
Drug Abuse Treatment Entry and Retention in the Community
entered community treatment within 10 days of release from prison (yes vs. no)
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bup+OTP | Drug Abuse Treatment Entry and Retention in the Community | 22 participants |
| Bup+CHC | Drug Abuse Treatment Entry and Retention in the Community | 26 participants |
| Counseling+OTP | Drug Abuse Treatment Entry and Retention in the Community | 23 participants |
| Counseling+CHC | Drug Abuse Treatment Entry and Retention in the Community | 11 participants |
Primary
Number of Days of Heroin Use
mean days used heroin during the past 30 days
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bup+OTP | Number of Days of Heroin Use | 6.0 days | Standard Deviation 11.4 |
| Bup+CHC | Number of Days of Heroin Use | 6.4 days | Standard Deviation 11.5 |
| Counseling+OTP | Number of Days of Heroin Use | 6.5 days | Standard Deviation 11.3 |
| Counseling+CHC | Number of Days of Heroin Use | 4.0 days | Standard Deviation 9 |
Secondary
Criminal Activity
Days of crime during the past 30 days
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bup+OTP | Criminal Activity | 3.4 days | Standard Deviation 9.4 |
| Bup+CHC | Criminal Activity | 5.4 days | Standard Deviation 11.4 |
| Counseling+OTP | Criminal Activity | 3.3 days | Standard Deviation 9.2 |
| Counseling+CHC | Criminal Activity | 3.2 days | Standard Deviation 9 |
Secondary
Employment Status
Number of days employed during the past year
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bup+OTP | Employment Status | 30.0 days | Standard Deviation 28.1 |
| Bup+CHC | Employment Status | 29.6 days | Standard Deviation 26.9 |
| Counseling+OTP | Employment Status | 22.3 days | Standard Deviation 32.4 |
| Counseling+CHC | Employment Status | 31.4 days | Standard Deviation 30.1 |
Secondary
HIV Risk Behavior
Number of times had sex without using a condom during the past year
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bup+OTP | HIV Risk Behavior | 59.7 times | Standard Deviation 52.6 |
| Bup+CHC | HIV Risk Behavior | 36.1 times | Standard Deviation 40.3 |
| Counseling+OTP | HIV Risk Behavior | 33.3 times | Standard Deviation 29.3 |
| Counseling+CHC | HIV Risk Behavior | 50.4 times | Standard Deviation 38.4 |
Secondary
HIV Risk Behavior Needle Sharing
Number of times shared a needle during the past year
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bup+OTP | HIV Risk Behavior Needle Sharing | 2.9 times | Standard Deviation 15.9 |
| Bup+CHC | HIV Risk Behavior Needle Sharing | .1 times | Standard Deviation 0.5 |
| Counseling+OTP | HIV Risk Behavior Needle Sharing | 2.1 times | Standard Deviation 13.6 |
| Counseling+CHC | HIV Risk Behavior Needle Sharing | .1 times | Standard Deviation 1.3 |
Secondary
Number of Days of Cocaine Use
Number of days used cocaine during the past 30 days.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bup+OTP | Number of Days of Cocaine Use | 1.1 days | Standard Deviation 4.3 |
| Bup+CHC | Number of Days of Cocaine Use | 4.1 days | Standard Deviation 9.5 |
| Counseling+OTP | Number of Days of Cocaine Use | 4.7 days | Standard Deviation 9.4 |
| Counseling+CHC | Number of Days of Cocaine Use | 2.7 days | Standard Deviation 6 |