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

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treatment as usual
Sponsored by
National Taiwan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Behavior drug and risk reduction counseling, Heroin, Addiction treatment, Randomization, Treatment effect

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    BDRC

    TAU

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in heroin use
    Testing patients' urine for heroin use

    Secondary Outcome Measures

    Number of treatment section
    How many counseling sessions attended by patients?

    Full Information

    First Posted
    October 23, 2018
    Last Updated
    October 25, 2018
    Sponsor
    National Taiwan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03721380
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 14, 2012 (Actual)
    Primary Completion Date
    July 31, 2014 (Actual)
    Study Completion Date
    July 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taiwan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use Disorders
    Keywords
    Behavior drug and risk reduction counseling, Heroin, Addiction treatment, Randomization, Treatment effect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    118 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BDRC
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    TAU
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as usual
    Other Intervention Name(s)
    Methadone treatment with Bi-weekly counseling using BDRC
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in heroin use
    Description
    Testing patients' urine for heroin use
    Time Frame
    3, 6, and 12 months
    Secondary Outcome Measure Information:
    Title
    Number of treatment section
    Description
    How many counseling sessions attended by patients?
    Time Frame
    Within 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tony Szu-Hsien Tony Szu-Hsien, Ph.D.
    Organizational Affiliation
    National Taiwan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21159452
    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.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/?term=Behavioral+drug+and+HIV+risk+reduction+counseling+(BDRC)+in+MMT+programs+in+Wuhan%2C+China%3A+a+pilot+randomized+clinical+trial.
    Description
    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).

    Learn more about this trial

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

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