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Trial record 1 of 1 for:    23260506 [PUBMED-IDS]
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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 : October 6, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Fiellin, Yale University

Study Type Interventional
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

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Physician Management Physician Management Plus Cognitive Behavioral Therapy
Hide Arm/Group Description 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
Arm/Group Title Physician Management Physician Management Plus Cognitive Behavioral Therapy Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 70 participants 141 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
71
 100.0%
70
 100.0%
141
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 71 participants 70 participants 141 participants
Female
18
  25.4%
19
  27.1%
37
  26.2%
Male
53
  74.6%
51
  72.9%
104
  73.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants 70 participants 141 participants
71 70 141
1.Primary Outcome
Title Illicit Opioid Abstinence
Hide Description number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Repeated measures analysis of variance was used to evaluate differences between groups in the maximum number of consecutive weeks of opioid abstinence for the first and second 12 weeks of treatment. We coded missing urine specimens as positive for opioids in our analysis, thus all participants provided data.
Arm/Group Title Physician Management Physician Management Plus Cognitive Behavioral Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: Weeks of Abstinence
10.29  (8.48) 10.12  (8.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physician Management, Physician Management Plus Cognitive Behavioral Therapy
Comments With an effect size of 0.46, a sample size of 140 will provide a power of >.84 with p<.05 to detect overall differences between the two treatments on the primary outcome measures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .91
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.40
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Treatment Completion
Hide Description The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who entered treatment were evaluated for treatment completion.
Arm/Group Title Physician Management Physician Management Plus Cognitive Behavioral Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Unit of Measure: participants
45 39
3.Secondary Outcome
Title Cocaine Abstinence
Hide Description Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants provided one or more urine screens thus data was based on all participants.
Arm/Group Title Physician Management Physician Management Plus Cognitive Behavioral Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: weeks of abstinence
12.4  (7.7) 13.8  (7.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physician Management, Physician Management Plus Cognitive Behavioral Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .29
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.32
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.
Hide Description The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed one or more ASI assessments were included in the analysis.
Arm/Group Title Physician Management Physician Management Plus Cognitive Behavioral Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 67 64
Mean (Standard Error)
Unit of Measure: Scores on a scale
.044  (.011) .066  (.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physician Management, Physician Management Plus Cognitive Behavioral Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .58
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Analysis to evaluate interaction of group by time.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .04
Parameter Dispersion
Type: Standard Error of the mean
Value: .029
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Health- Short Form (36) Health Survey
Hide Description

Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales.

The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning.

Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed 1 or more SF-36 assessments were included in the analysis.
Arm/Group Title Physician Management Physician Management Plus Cognitive Behavioral Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 70 69
Mean (Standard Error)
Unit of Measure: Scores on a scale
75.3  (1.7) 75.1  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physician Management, Physician Management Plus Cognitive Behavioral Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .24
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Analysis to evaluate interaction of group by time.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.63
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Physician Management Physician Management Plus Cognitive Behavioral Therapy
Hide Arm/Group Description 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.
All-Cause Mortality
Physician Management Physician Management Plus Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Physician Management Physician Management Plus Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Physician Management Physician Management Plus Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/70 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David Fiellin
Organization: Yale University
Phone: 203-737-3347
Responsible Party: David Fiellin, Yale University
ClinicalTrials.gov Identifier: NCT00595764     History of Changes
Obsolete Identifiers: NCT00632151
Other Study ID Numbers: 5R01DA019511 ( U.S. NIH Grant/Contract )
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: October 6, 2014