NCT03644719

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

2.6 years

First QC Date

August 12, 2018

Last Update Submit

August 21, 2018

Conditions

Keywords

Substance AbuseCognitive behavioral treatmentKetamineStage of Change

Outcome Measures

Primary Outcomes (1)

  • Motivation to change

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

    15 minutes

Secondary Outcomes (1)

  • Knowledge about ketamine

    3 minutes

Study Arms (2)

Cognitive behavior skills training

EXPERIMENTAL

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

Education as usual

NO INTERVENTION

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.

Interventions

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.

Cognitive behavior skills training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • no brain damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Tony Szu-Hsien Lee, Ph.D.

    Health Promotion and Health Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 23, 2018

Study Start

August 19, 2014

Primary Completion

March 19, 2017

Study Completion

March 19, 2017

Last Updated

August 23, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share