- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03644719
Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers
August 21, 2018 updated by: Tony Szu-Hsien Lee, National Taiwan University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ketamine use in 30 days
- more than 18 years old
Exclusion Criteria:
- no brain damage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation to change
Time Frame: 15 minutes
|
Stage of Change Scale: Have you thought of abstaining from Ketamine?
In 30 days?
In six months?
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge about ketamine
Time Frame: 3 minutes
|
5 items questionnaire about consequences of using ketamine: micturition, perception distortion, depression, behavioral inhibition and memory
|
3 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tony Szu-Hsien Lee, Ph.D., Health Promotion and Health Education
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2014
Primary Completion (Actual)
March 19, 2017
Study Completion (Actual)
March 19, 2017
Study Registration Dates
First Submitted
August 12, 2018
First Submitted That Met QC Criteria
August 21, 2018
First Posted (Actual)
August 23, 2018
Study Record Updates
Last Update Posted (Actual)
August 23, 2018
Last Update Submitted That Met QC Criteria
August 21, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chronic Ketamine Abusers
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.