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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Physician Management 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.
Physician Management Plus Cognitive Behavioral Therapy 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.

Participant Flow:   Overall Study
    Physician Management   Physician Management Plus Cognitive Behavioral Therapy
STARTED   71   70 
COMPLETED   32   27 
NOT COMPLETED   39   43 
Protocol Violation                24                19 
Missed Medication >1 week                10                17 
Missed 3 PM visits                1                7 
Withdrawal by Subject                4                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Physician Management 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.
Physician Management Plus Cognitive Behavioral Therapy 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 Total of all reporting groups

Baseline Measures
   Physician Management   Physician Management Plus Cognitive Behavioral Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   70   141 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   71   70   141 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.5  (10.3)   32.8  (8.6)   33.6  (9.5) 
Gender 
[Units: Participants]
     
Female   18   19   37 
Male   53   51   104 
Region of Enrollment 
[Units: Participants]
     
United States   71   70   141 


  Outcome Measures

1.  Primary:   Illicit Opioid Abstinence   [ Time Frame: 6 months ]

2.  Secondary:   Treatment Completion   [ Time Frame: 6 months ]

3.  Secondary:   Cocaine Abstinence   [ Time Frame: 6 months ]

4.  Secondary:   Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.   [ Time Frame: 6 months ]

5.  Secondary:   Overall Health- Short Form (36) Health Survey   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: david.fiellin@yale.edu


Publications of Results:

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