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Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioral skills training
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 Substance Abuse, Cognitive behavioral treatment, Ketamine, Stage of Change

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ketamine use in 30 days
  • more than 18 years old

Exclusion Criteria:

  • no brain damage

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Cognitive behavior skills training

    Education as usual

    Arm Description

    The first session is intended to establish rapport, build therapeutic cohesion through ice-breaking activities, and educate participants about the drug regulations stated in the Statute for Drug Hazard Prevention and Control. The following four sessions are devoted to interactively practicing refusal skills, communication skills, decision-making skills, and positive conflict resolution skills. The final session is to review what has been learned and reminds participants about the association of drug use with HIV/HCV.

    The EAU group received six hours of informational lectures about ketamine, its effects on the brain, relevant regulations and laws, and the risks and modes of transmission of infectious diseases, including HIV and hepatitis C.

    Outcomes

    Primary Outcome Measures

    Motivation to change
    Stage of Change Scale: Have you thought of abstaining from Ketamine? In 30 days? In six months?

    Secondary Outcome Measures

    Knowledge about ketamine
    5 items questionnaire about consequences of using ketamine: micturition, perception distortion, depression, behavioral inhibition and memory

    Full Information

    First Posted
    August 12, 2018
    Last Updated
    August 21, 2018
    Sponsor
    National Taiwan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03644719
    Brief Title
    Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers
    Official Title
    Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 19, 2014 (Actual)
    Primary Completion Date
    March 19, 2017 (Actual)
    Study Completion Date
    March 19, 2017 (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
    In recent years ketamine abuse becomes prevalent in youth in some Asian countries. Chronic ketamine abuse may lead to uropathology and cognitive impairments. No pharmacological interventions have been identified as effective for treating ketamine abuse or helpful in achieving or maintaining abstinence from ketamine. Cognitive-behavioral treatment is currently an important psychosocial intervention for addictive problems. This study aimed to test whether a brief cognitive-behavioral training program has a positive influence on stage transitions among ketamine abusers.
    Detailed Description
    409 ketamine abusers were recruited in this study, with 285 ketamine abusers participated in a 6-hour brief cognitive-behavioral intervention and 124 ketamine abusers attended educational lectures on ketamine abuse. A brief cognitive-behavioral intervention was applied to teach ketamine abusers about stimulus control, refusal skills, communication skills, decisional balance, and infectious diseases prevention. Stage of Change and knowledge about ketamine were assessed before and after the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use Disorders
    Keywords
    Substance Abuse, Cognitive behavioral treatment, Ketamine, Stage of Change

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Two arms were used to examine the relative effect of the cognitive behavioral skills training (CBSR) and a time slot for education as usual (EAU). The CBST consists of six sessions. The first session is intended to establish rapport, build therapeutic cohesion through ice-breaking activities, and educate participants about the drug regulations stated in the Statute for Drug Hazard Prevention and Control. The following four sessions are devoted to interactively practicing refusal skills, communication skills, decision-making skills, and positive conflict resolution skills. The final session is to review what has been learned and reminds participants about the association of drug use with HIV/HCV.
    Masking
    Participant
    Masking Description
    Participants signed up for a time slot for cognitive behavioral skills training (CBST) or a time slot for education as usual (EAU), without being informed which was which.
    Allocation
    Non-Randomized
    Enrollment
    409 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive behavior skills training
    Arm Type
    Experimental
    Arm Description
    The first session is intended to establish rapport, build therapeutic cohesion through ice-breaking activities, and educate participants about the drug regulations stated in the Statute for Drug Hazard Prevention and Control. The following four sessions are devoted to interactively practicing refusal skills, communication skills, decision-making skills, and positive conflict resolution skills. The final session is to review what has been learned and reminds participants about the association of drug use with HIV/HCV.
    Arm Title
    Education as usual
    Arm Type
    No Intervention
    Arm Description
    The EAU group received six hours of informational lectures about ketamine, its effects on the brain, relevant regulations and laws, and the risks and modes of transmission of infectious diseases, including HIV and hepatitis C.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive behavioral skills training
    Intervention Description
    A brief cognitive behavioral skills training was applied to teach ketamine abusers about stimulus control, refusal skills, communication skills, decisional balance, and infectious diseases prevention.
    Primary Outcome Measure Information:
    Title
    Motivation to change
    Description
    Stage of Change Scale: Have you thought of abstaining from Ketamine? In 30 days? In six months?
    Time Frame
    15 minutes
    Secondary Outcome Measure Information:
    Title
    Knowledge about ketamine
    Description
    5 items questionnaire about consequences of using ketamine: micturition, perception distortion, depression, behavioral inhibition and memory
    Time Frame
    3 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ketamine use in 30 days more than 18 years old Exclusion Criteria: no brain damage
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tony Szu-Hsien Lee, Ph.D.
    Organizational Affiliation
    Health Promotion and Health Education
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15733250
    Citation
    Baker A, Lee NK, Claire M, Lewin TJ, Grant T, Pohlman S, Saunders JB, Kay-Lambkin F, Constable P, Jenner L, Carr VJ. Brief cognitive behavioural interventions for regular amphetamine users: a step in the right direction. Addiction. 2005 Mar;100(3):367-78. doi: 10.1111/j.1360-0443.2005.01002.x.
    Results Reference
    result
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/?term=Brief+cognitive+behavioural+interventions+for+regular+amphetamine+users%3A+a+step+in+the+right+direction.+Addiction
    Description
    This study demonstrated that brief interventions consisting of cognitive behavior therapy increased the likelihood of abstinence from amphetamines among those receiving two or more treatment sessions.

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    Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers

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