Counseling for Primary Care Office-based Buprenorphine
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ClinicalTrials.gov Identifier: NCT00595764 |
Recruitment Status :
Completed
First Posted : January 16, 2008
Results First Posted : October 6, 2014
Last Update Posted : April 3, 2020
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Sponsor:
Yale University
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Opiate Dependence |
Interventions |
Behavioral: Manual-guided Physician Management (PM) Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) |
Enrollment | 141 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Physician Management | Physician Management Plus Cognitive Behavioral Therapy |
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Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups. | In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills. |
Period Title: Overall Study | ||
Started | 71 | 70 |
Completed | 32 | 27 |
Not Completed | 39 | 43 |
Reason Not Completed | ||
Protocol Violation | 24 | 19 |
Missed Medication >1 week | 10 | 17 |
Missed 3 PM visits | 1 | 7 |
Withdrawal by Subject | 4 | 0 |
Baseline Characteristics
Arm/Group Title | Physician Management | Physician Management Plus Cognitive Behavioral Therapy | Total | |
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Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups. | In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills. | Total of all reporting groups | |
Overall Number of Baseline Participants | 71 | 70 | 141 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 71 participants | 70 participants | 141 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
71 100.0%
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70 100.0%
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141 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 71 participants | 70 participants | 141 participants | |
34.5 (10.3) | 32.8 (8.6) | 33.6 (9.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 71 participants | 70 participants | 141 participants | |
Female |
18 25.4%
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19 27.1%
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37 26.2%
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Male |
53 74.6%
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51 72.9%
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104 73.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 71 participants | 70 participants | 141 participants |
71 | 70 | 141 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. David Fiellin |
Organization: | Yale University |
Phone: | 203-737-3347 |
EMail: | david.fiellin@yale.edu |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT00595764 |
Obsolete Identifiers: | NCT00632151 |
Other Study ID Numbers: |
0504027657 5R01DA019511 ( U.S. NIH Grant/Contract ) |
First Submitted: | October 3, 2007 |
First Posted: | January 16, 2008 |
Results First Submitted: | July 18, 2013 |
Results First Posted: | October 6, 2014 |
Last Update Posted: | April 3, 2020 |