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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DA019838-03 | U.S. NIH Grant/Contract | View source | |
| 7R21DA019838-02 | 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 study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.
This study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially, 9 women were enrolled and received buprenorphine medication. After the first 9 participants, women were randomized to either buprenorphine or placebo. Women received the buprenorphine medication for 12 weeks in the community and at the end of the 12 weeks were transitioned either to another buprenorphine provider, methadone provider, or tapered off buprenorphine based on the participant's preferences. One additional follow-up at 3 months after treatment was conducted. The primary outcome was opioid positive urines at all time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine | Experimental | Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months |
|
| Placebo | Placebo Comparator | Placebo sublingual medication provided to individuals randomized to control up to 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo to match buprenorphine administered for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. | Number of participants with positive opiate urine samples at 12 weeks of treatment. | 12 weeks |
| Opiate Positive Urines With Missing Urines Coded as Positive at Week 24. | Number of participants with positive opiate urine sample at the 24 week follow-up. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Enroll in the Study. | To determine the number of participants who enroll in the study during the time of recruitment. | up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Initially, 11 women were enrolled in the open-label trial, followed by 33 women randomized to either buprenorphine or placebo.
Recruitment began in May of 2008 and ended June of 2010. All participants were recruited from a 28-day drug inpatient facility that accepts patients from the criminal justice system.
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine | Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment. |
| FG001 | Placebo | Medication "sugar pill" provided for 12 weeks up to 32 mg daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine | Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment. |
| BG001 | Placebo | Medication "sugar pill" provided for 12 weeks up to 32 mg daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. | Number of participants with positive opiate urine samples at 12 weeks of treatment. | All subjects were included in the analysis population as intent to treat. | Posted | Feb 2010 | Number | participants | 12 weeks |
|
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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 | Buprenorphine | Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment. |
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Slow recruitment with poor retention. Transient population that was difficult to effectively track.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Cropsey | University of Alabama at Birmingham | 205-917-3786 | 205 | kcropsey@uab.edu |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Buprenorphine |
| Drug |
Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily. |
|
| Believed they were receiving placebo |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| Secondary | Number of Participants Who Enroll in the Study. | To determine the number of participants who enroll in the study during the time of recruitment. | Posted | Number | participants | up to 24 months |
|
|
|
| Primary | Opiate Positive Urines With Missing Urines Coded as Positive at Week 24. | Number of participants with positive opiate urine sample at the 24 week follow-up. | All subjects were included in the analysis population as intent to treat. | Posted | Number | participants | 24 weeks |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Placebo | Medication "sugar pill" provided for 12 weeks up to 32 mg daily. | 0 | 16 | 0 | 16 |
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| 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 |