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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA021579 | U.S. NIH Grant/Contract | View source | |
| 1R01DA021579-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine+OTP | Experimental | Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release. |
|
| Buprenorphine+CHC | Experimental | Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release. |
|
| Counseling + OTP | Active Comparator | Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP) |
|
| Counseling + CHC | Active Comparator | Counseling only in prisons and Buprenorphine upon release at a community health center (CHC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine +OTP | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Heroin Use | mean days used heroin during the past 30 days | 1 year |
| Drug Abuse Treatment Entry and Retention in the Community | entered community treatment within 10 days of release from prison (yes vs. no) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Cocaine Use | Number of days used cocaine during the past 30 days. | 1 year |
| Criminal Activity | Days of crime during the past 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan Transition Center | Baltimore | Maryland | 21201 | United States | ||
| Maryland Correctional Institution for Women |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20473351 | Background | Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT. Developing and Implementing a New Prison-Based Buprenorphine Treatment Program. J Offender Rehabil. 2010 Feb;49(2):91-109. doi: 10.1080/10509670903534951. | |
| 25392564 | Background | Gordon MS, Kinlock TW, Schwartz RP, Couvillion KA, O'Grady KE. The Severity, Frequency, and Variety of Crime in Heroin-Dependent Prisoners Enrolled in a Buprenorphine Clinical Trial. Prison J. 2013 Dec 1;93(4):390-410. doi: 10.1177/0032885513500753. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bup+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 |
| FG001 | Bup+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. |
| FG002 | Counseling+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. |
| FG003 | Counseling+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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days of Heroin Use | mean days used heroin during the past 30 days | Posted | Mean | Standard Deviation | days | 1 year |
|
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0 represents other [non-serious] adverse events were not collected/assessed during the 12-months post-release time period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Gordon | Friends Research Institute | 410-837-3977 | 251 | mgordon@friendsresearch.org |
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| ID | Term |
|---|---|
| D006556 | Heroin Dependence |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
|
| Buprenorphine +CHC | Drug | 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. |
|
|
| Counseling +OTP | Drug | 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. |
|
|
| Counseling +CHC | Drug | 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. |
|
|
| 1 year |
| Employment Status | Number of days employed during the past year | 1 year |
| HIV Risk Behavior Needle Sharing | Number of times shared a needle during the past year | 1 year |
| HIV Risk Behavior | Number of times had sex without using a condom during the past year | 1 year |
| Jessup |
| Maryland |
| 20794 |
| United States |
| 31787108 | Derived | Blue TR, Gordon MS, Schwartz RP, Couvillion K, Vocci FJ, Fitzgerald TT, O'Grady KE. Longitudinal analysis of HIV-risk behaviors of participants in a randomized trial of prison-initiated buprenorphine. Addict Sci Clin Pract. 2019 Dec 2;14(1):45. doi: 10.1186/s13722-019-0172-2. |
| BG001 |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Counseling+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. |
| OG003 | Counseling+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. |
|
|
| Primary | Drug Abuse Treatment Entry and Retention in the Community | entered community treatment within 10 days of release from prison (yes vs. no) | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Number of Days of Cocaine Use | Number of days used cocaine during the past 30 days. | Posted | Mean | Standard Deviation | days | 1 year |
|
|
|
| Secondary | Criminal Activity | Days of crime during the past 30 days | Posted | Mean | Standard Deviation | days | 1 year |
|
|
|
| Secondary | Employment Status | Number of days employed during the past year | Posted | Mean | Standard Deviation | days | 1 year |
|
|
|
| Secondary | HIV Risk Behavior Needle Sharing | Number of times shared a needle during the past year | Posted | Mean | Standard Deviation | times | 1 year |
|
|
|
| Secondary | HIV Risk Behavior | Number of times had sex without using a condom during the past year | Posted | Mean | Standard Deviation | times | 1 year |
|
|
|
| 4 |
| 52 |
| 0 |
| 0 |
| EG001 | 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. | 14 | 52 | 0 | 0 |
| EG002 | 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. | 10 | 54 | 0 | 0 |
| EG003 | 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. | 10 | 53 | 0 | 0 |
| back injury | Injury, poisoning and procedural complications | Systematic Assessment | fell off ladder. |
|
| swollen foot | Investigations | Systematic Assessment |
|
| unkown | Investigations | Non-systematic Assessment | We were unable to obtain hospital medical records |
|
| depression | Psychiatric disorders | Systematic Assessment |
|
| kidney problem | Infections and infestations | Systematic Assessment |
|
| physical assualt | Investigations | Systematic Assessment |
|
| blood clot | Blood and lymphatic system disorders | Systematic Assessment |
|
| influenza | Infections and infestations | Systematic Assessment |
|
| alcohol withdrawal | Investigations | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment |
|
| cesarean birth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| neck pain | Investigations | Non-systematic Assessment |
|
| shoulder pain | Investigations | Non-systematic Assessment |
|
| pregnancy compplications | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| pneumonia | Infections and infestations | Systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| ulcer | General disorders | Systematic Assessment |
|
| allergic reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| gallstones | Gastrointestinal disorders | Systematic Assessment |
|
| hysterectomy | Surgical and medical procedures | Systematic Assessment |
|
| cellulitis in right arm and leg | Blood and lymphatic system disorders | Systematic Assessment |
|
| osteomyelitis and soft tissue infection of the cervical spine | Investigations | Systematic Assessment |
|
| seizure | General disorders | Systematic Assessment |
|
| meningitis | Infections and infestations | Systematic Assessment |
|
| pregnancy complications | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |