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

NCT03721380 | Completed

• 1 other identifier: BDRC
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Substance Use Disorders

Keywords

Behavior drug and risk reduction counseling; Heroin; Addiction treatment; Randomization; Treatment effect

Outcome Measures

Primary Outcomes (1)

• Change in heroin use

  Testing patients' urine for heroin use

  3, 6, and 12 months

Secondary Outcomes (1)

• Number of treatment section

  Within 6 months

Study Arms (2)

BDRC

EXPERIMENTAL

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

TAU

OTHER

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

Interventions

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.

Also known as: Methadone treatment with Bi-weekly counseling using BDRC

BDRC; TAU

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment in opioid substitution treatment
• Injected heroin within past 30 days by self-report, documented by "tracks" or puncture marks
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University: lead

Related 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 2010 Dec 14.

  PMID: 21159452 RESULT

Related 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).

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Tony Szu-Hsien Tony Szu-Hsien, Ph.D.

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 26, 2018
• Study Start: May 14, 2012
• Primary Completion: July 31, 2014
• Study Completion: July 31, 2015
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share