Opiate Dependence
Conditions
Keywords
Buprenorphine, Buprenorphine/naloxone, Counseling, Primary care
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.
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.
Interventions
BEHAVIORALManual-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.
BEHAVIORALPhysician 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Cocaine Abstinence | 6 months | Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| 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. | 70 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missed 3 PM visits | 1 | 7 |
| Overall Study | Missed Medication >1 week | 10 | 17 |
| Overall Study | Protocol Violation | 24 | 19 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Physician Management Plus Cognitive Behavioral Therapy | Physician Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 71 Participants | 141 Participants |
| Age, Continuous | 32.8 years STANDARD_DEVIATION 8.6 | 34.5 years STANDARD_DEVIATION 10.3 | 33.6 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 70 participants | 71 participants | 141 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 51 Participants | 53 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 71 | 0 / 70 |
| serious Total, serious adverse events | 0 / 71 | 0 / 70 |
Outcome results
Primary
Illicit Opioid Abstinence
number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physician Management | Illicit Opioid Abstinence | 10.29 Weeks of Abstinence | Standard Deviation 8.48 |
| Physician Management Plus Cognitive Behavioral Therapy | Illicit Opioid Abstinence | 10.12 Weeks of Abstinence | Standard Deviation 8.07 |
Comparison: 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.p-value: 0.91ANOVA
Secondary
Cocaine Abstinence
Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.
Time frame: 6 months
Population: All participants provided one or more urine screens thus data was based on all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physician Management | Cocaine Abstinence | 12.4 weeks of abstinence | Standard Deviation 7.7 |
| Physician Management Plus Cognitive Behavioral Therapy | Cocaine Abstinence | 13.8 weeks of abstinence | Standard Deviation 7.9 |
p-value: 0.29t-test, 2 sided
Secondary
Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.
The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.
Time frame: 6 months
Population: All participants who completed one or more ASI assessments were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physician Management | Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score. | .044 Scores on a scale | Standard Error 0.011 |
| Physician Management Plus Cognitive Behavioral Therapy | Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score. | .066 Scores on a scale | Standard Error 0.01 |
p-value: 0.58Mixed Models Analysis
Secondary
Overall Health- Short Form (36) Health Survey
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
Population: All participants who completed 1 or more SF-36 assessments were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physician Management | Overall Health- Short Form (36) Health Survey | 75.3 Scores on a scale | Standard Error 1.7 |
| Physician Management Plus Cognitive Behavioral Therapy | Overall Health- Short Form (36) Health Survey | 75.1 Scores on a scale | Standard Error 1.6 |
p-value: 0.24Mixed Models Analysis
Secondary
Treatment Completion
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
Population: All participants who entered treatment were evaluated for treatment completion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Physician Management | Treatment Completion | 45 participants |
| Physician Management Plus Cognitive Behavioral Therapy | Treatment Completion | 39 participants |