Efficacy of Drug and Risk Behavior Counseling Intervention Among Injecting Drug Users at Opioid Substitution Treatment

Study Overview
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Brief Summary
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Behavior drug and risk reduction counseling (BDRC), a structured, non-intense, cognitive-behavioral approach intervention designed to increase methadone maintenance treatment retention and reduce drug use and related risk behaviors among IDUs.

Detailed Description
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Techniques of the Cognitive Behavior Therapy combined with drug dependence psychoeducation was developed by research team. BDRC consists of 12 sessions, including an initial session, 3 drug education sesssions, psychosocial counseling and behavioral skills. This initial session is designed to introduce the counselor, review the purpose and expectations of counseling, review the rules of confidentiality, agree on attendance times and rescheduling rules, and to begin to collect information from the participant on their drug use and risk behaviors. Behavioral contracting is a key component to this counseling approach. Drug education focuses on how heroin may influence patients' cognitive function and their HIV/HCV risk behaviors. Counseling and behavior skills trained patients to reflect their thoughts and learned new life skills in order to delay or abstrain from heroin use.

Official Title
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Efficacy of Drug and Risk Behavior Counseling Intervention Among Injecting Drug Users at Opioid Substitution Treatment

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment in opioid substitution treatment Injected heroin within past 30 days by self-report, documented by tracks or puncture marks 20 or more years of age Meets ICD-10 criteria for opiates dependence with physiologic features Agrees to keep bi-weekly appointments if selected Current address within Taipei and Keelung, and not planning to move Willingness and ability to give informed consent and otherwise participate Provision of adequate locator information Exclusion Criteria: Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder Advanced neurological, cardiovascular, renal, or other medical disorder that is likely to impair or make hazardous patient's ability to participate Physiologically dependent on alcohol, benzodiazepines or other sedative type drugs Concurrent participation in another treatment study Planning to enter inpatient or residential treatment within next year Pending legal charges with likely incarceration within next 12 months

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BDRC<br>At the time of assignment to the counseling intervention arm of the study, there will be an initial meeting between the subject and the assigned counselor. As described in the counseling manual, this initial session is designed to introduce the counselor, review the purpose and expectations of counseling, review the rules of confidentiality, agree on attendance times and rescheduling rules, and to begin to collect information from the participant on their drug use and risk behaviors. Behavioral contracting is a key component to this counseling approach. | Behavioral: Treatment as usual<br>* Patients receive some HIV risk education for the enrollment; after that, health education is delivered irregularly (1-2 times a month or none), based on the patient's needs. During MMT treatment, the participant receives monthly random urine testing for opiate use and HIV testing as needed. Monthly meetings between the patient and physician are expected to occur however, there is no structure to these sessions and content is considered to be quite variable.<br>* Other names: Methadone treatment with Bi-weekly counseling using BDRC;|
| Other: TAU<br>Patients receive some HIV risk education for the enrollment; after that, health education is delivered irregularly (1-2 times a month or none), based on the patient's needs. | Behavioral: Treatment as usual<br>* Patients receive some HIV risk education for the enrollment; after that, health education is delivered irregularly (1-2 times a month or none), based on the patient's needs. During MMT treatment, the participant receives monthly random urine testing for opiate use and HIV testing as needed. Monthly meetings between the patient and physician are expected to occur however, there is no structure to these sessions and content is considered to be quite variable.<br>* Other names: Methadone treatment with Bi-weekly counseling using BDRC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heroin use | Testing patients' urine for heroin use | 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment section | How many counseling sessions attended by patients? | Within 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior drug and risk reduction counseling, Heroin, Addiction treatment, Randomization, Treatment effect