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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721380
• Other study ID #: BDRC
• Status: Completed
• Phase: N/A
• Start date: May 14, 2012
• Est. completion date: July 31, 2015

Study information

• Verified date: October 2018
• Source: National Taiwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 31, 2015
• Est. primary completion date: July 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Treatment as usual
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University

References & Publications (1)

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heroin use	Testing patients' urine for heroin use	3, 6, and 12 months
Secondary	Number of treatment section	How many counseling sessions attended by patients?	Within 6 months

External Links

•   This pilot clinical trial evaluated whether the efficacy of methadone maintenance treatment (MMT) provided with limited psychosocial services is improved by the addition of manual-guided behavioral drug and HIV risk reduction counseling (BDRC).