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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC1DA028407-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.
This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Outpatient | Experimental | Buprenorphine patients receiving 9 or more hours of outpatient counseling. |
|
| Outpatient | Active Comparator | Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient | Behavioral | Buprenorphine patients receiving 2 to 8 hours of outpatient counseling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) | 6 months post-baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon G Mitchell, PhD | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Research Institute | Baltimore | Maryland | 21201 | United States |
345 patients were randomized. Of those, the following participants were excluded from the study shortly after random assignment: 21 were from the discontinued site, 2 were dropped because of non-standard clinic treatment track, 1 voluntarily withdrew, 2 were erroneously re-enrolled. We also excluded 19 non-African Americans, per study protocol.
New patients entering buprenorphine treatment at one of the two participating outpatient "drug-free" treatment programs were block randomized to either intensive outpatient treatment (IOP) or standard outpatient treatment (OP). The study initially included a third clinic site, which was dropped due to insufficient enrollment at that site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Outpatient | Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling. |
| FG001 | Outpatient | Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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21 were from the discontinued site, 2 dropped because participant was non-regular treatment track, 1 voluntarily withdrew from the study, 1 was erroneously re-enrolled after being re-admitted to the same clinic, and 1 was erroneously re-enrolled, and 19 were not African American.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Outpatient | Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling. |
| BG001 | Outpatient |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) | Posted | Number | percentage of opioid dependent subjects | 6 months post-baseline |
|
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serious and/or other [non-serious] adverse events were not collected/assessed
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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 | Intensive Outpatient | Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling. |
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OP condition participants received more counseling services at the clinics as part of their regular care than was initially expected and IOP condition participants received slightly less that 9 hours of counseling, on average.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shannon Gwin Mitchell | Friends Research Institute | 410-837-3977 | 238 | smitchell@friendsresearch.org |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| Intensive Outpatient | Behavioral | Buprenorphine patients receiving 9 or more hours of outpatient counseling. |
|
| clinic readmission |
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| Withdrawal by Subject |
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| non-African American participant |
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| Lost to Follow-up |
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Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Outpatient | Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling. | 0 | 0 | 0 | 0 |
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