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

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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as Usual

Behavioral

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.

Other names: Methadone treatment with Bi-weekly counseling using BDRC

Primary outcomes

Change in heroin use

Time frame: 3, 6, and 12 months

Testing patients' urine for heroin use

Secondary outcomes

Number of treatment section

Time frame: Within 6 months

How many counseling sessions attended by patients?

Sponsors and collaborators

Lead sponsor

National Taiwan University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Oct 26, 2018
Registry last updated: Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed