Counseling for Primary Care Office-based Buprenorphine

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00595764
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 141
• Locations: 2
• Arms: 2
• Duration (Months): 66
• Patients Per Site: 70.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The major goal is to determine whether adding cognitive behavioral therapy to physician management will increase the efficacy of buprenorphine/naloxone treatment in an office-based primary care setting.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Behavioral: Manual-guided Physician Management (PM); Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)	Phase 4

Detailed Description

To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved buprenorphine/naloxone adherence and will demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with buprenorphine/naloxone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 141 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Counseling for Primary Care Office-based Buprenorphine
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Physician Management	Behavioral: Manual-guided Physician Management (PM); Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.
Experimental: 2 Physician Management plus Cognitive Behavioral Therapy	Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT); CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.

Outcome Measures

Primary Outcome Measures

1. Illicit Opioid Abstinence [6 months]

   number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.

Secondary Outcome Measures

1. Treatment Completion [6 months]

   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.

2. Cocaine Abstinence [6 months]

   Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.

3. Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score. [6 months]

   The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.

4. Overall Health- Short Form (36) Health Survey [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• opioid dependence

Exclusion Criteria:

• current dependence on alcohol, cocaine, benzodiazepines or sedatives

• current suicide or homicide risk

• current psychotic disorder or untreated major depression

• inability to read or understand English

• life-threatening or unstable medical problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The APT Foundation, Inc. -- Welch Building	New Haven	Connecticut	United States	06519
2	Yale New Haven Hospital Primary Care Center	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: David A. Fiellin, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00595764
• Other Study ID Numbers: 0504027657; 5R01DA019511; NCT00632151
• First Posted: Jan 16, 2008
• Last Update Posted: Apr 3, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Yale University: Buprenorphine; Buprenorphine/naloxone; Counseling; Primary care
• Additional relevant MeSH terms: Opioid-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Physician Management	Physician Management Plus Cognitive Behavioral Therapy
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

Baseline Characteristics

Arm/Group Title	Physician Management	Physician Management Plus Cognitive Behavioral Therapy	Total
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 Participants	71	70	141
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	71 100%	70 100%	141 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.5 (10.3)	32.8 (8.6)	33.6 (9.5)
Sex: Female, Male (Count of Participants)
Female	18 25.4%	19 27.1%	37 26.2%
Male	53 74.6%	51 72.9%	104 73.8%
Region of Enrollment (participants) [Number]
United States	71 100%	70 100%	141 100%

Outcome Measures

1. Primary Outcome

Title	Illicit Opioid Abstinence
Description	number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.
Time Frame	6 months

Outcome Measure Data

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
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.
Measure Participants	71	70
Mean (Standard Deviation) [Weeks of Abstinence]	10.29 (8.48)	10.12 (8.07)

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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.91
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.40
	Estimation Comments

2. Secondary Outcome

Title	Treatment Completion
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

Outcome Measure Data

Analysis Population Description

All participants who entered treatment were evaluated for treatment completion.

Arm/Group Title	Physician Management	Physician Management Plus Cognitive Behavioral Therapy
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.
Measure Participants	71	70
Number [participants]	45 63.4%	39 55.7%

3. Secondary Outcome

Title	Cocaine Abstinence
Description	Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.
Time Frame	6 months

Outcome Measure Data

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
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.
Measure Participants	71	70
Mean (Standard Deviation) [weeks of abstinence]	12.4 (7.7)	13.8 (7.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physician Management, Physician Management Plus Cognitive Behavioral Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.29
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.40
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.32
	Estimation Comments

4. Secondary Outcome

Title	Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.
Description	The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.
Time Frame	6 months

Outcome Measure Data

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
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.
Measure Participants	67	64
Mean (Standard Error) [Scores on a scale]	.044 (.011)	.066 (.010)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physician Management, Physician Management Plus Cognitive Behavioral Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.58
	Comments
	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
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .029
	Estimation Comments

5. Secondary Outcome

Title	Overall Health- Short Form (36) Health Survey
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

Outcome Measure Data

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
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.
Measure Participants	70	69
Mean (Standard Error) [Scores on a scale]	75.3 (1.7)	75.1 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physician Management, Physician Management Plus Cognitive Behavioral Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.24
	Comments
	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
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.63
	Estimation Comments

Adverse Events

Arm/Group Title	Physician Management		Physician Management Plus Cognitive Behavioral Therapy
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Physician Management		Physician Management Plus Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Physician Management		Physician Management Plus Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/70 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.