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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03721380
Enrollment
118
Registered
2018-10-26
Start date
2012-05-14
Completion date
2015-07-31
Last updated
2018-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

Keywords

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

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.

Interventions

BEHAVIORALTreatment 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.

Sponsors

National Taiwan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in heroin use3, 6, and 12 monthsTesting patients' urine for heroin use

Secondary

MeasureTime frameDescription
Number of treatment sectionWithin 6 monthsHow many counseling sessions attended by patients?

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026