Clinical trial NCT03721380: Efficacy of Drug and Risk Behavior Counseling Intervention Among Injecting Drug Users at Opioid Substitution Treatment
Official title: Efficacy of Drug and Risk Behavior Counseling Intervention Among Injecting Drug Users at Opioid Substitution Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Behavior drug and risk reduction counseling
Heroin
Addiction treatment
Randomization
Treatment effect
Lead sponsor: National Taiwan University
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 118
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in heroin use
timeFrame: 3, 6, and 12 months
Secondary outcomes:
measure: Number of treatment section
timeFrame: Within 6 months
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University
name: Tony Szu-Hsien Tony Szu-Hsien, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chawarski MC, Zhou W, Schottenfeld RS. Behavioral drug and HIV risk reduction counseling (BDRC) in MMT programs in Wuhan, China: a pilot randomized clinical trial. Drug Alcohol Depend. 2011 Jun 1;115(3):237-9. doi: 10.1016/j.drugalcdep.2010.09.024. Epub 2010 Dec 14.