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

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ClinicalTrials.gov Identifier: NCT03644719
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Tony Szu-Hsien Lee, National Taiwan University

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Cognitive behavioral skills training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers
Actual Study Start Date : August 19, 2014
Actual Primary Completion Date : March 19, 2017
Actual Study Completion Date : March 19, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Cognitive behavior skills training
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.
Behavioral: Cognitive behavioral skills training
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.

No Intervention: Education as usual
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.



Primary Outcome Measures :
  1. Motivation to change [ Time Frame: 15 minutes ]
    Stage of Change Scale: Have you thought of abstaining from Ketamine? In 30 days? In six months?


Secondary Outcome Measures :
  1. Knowledge about ketamine [ Time Frame: 3 minutes ]
    5 items questionnaire about consequences of using ketamine: micturition, perception distortion, depression, behavioral inhibition and memory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no brain damage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644719


Sponsors and Collaborators
National Taiwan University
Investigators
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Principal Investigator: Tony Szu-Hsien Lee, Ph.D. Health Promotion and Health Education

Additional Information:
Publications of Results:
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Responsible Party: Tony Szu-Hsien Lee, Professor, National Taiwan University
ClinicalTrials.gov Identifier: NCT03644719     History of Changes
Other Study ID Numbers: Chronic Ketamine Abusers
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tony Szu-Hsien Lee, National Taiwan University:
Substance Abuse
Cognitive behavioral treatment
Ketamine
Stage of Change
Additional relevant MeSH terms:
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Ketamine
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action