Substance Use DisordersNCT03644719
Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers
A study testing Cognitive behavioral skills training in people with Substance Use Disorders, run by National Taiwan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Cognitive behavioral skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2014to 19 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ketamine use in 30 days
- more than 18 years old
Who cannot join
- no brain damage
About this study
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Cognitive behavioral skills training
- Keywords
- Substance Abuse, Cognitive behavioral treatment, Ketamine, Stage of Change
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral skills trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation to change
Stage of Change Scale: Have you thought of abstaining from Ketamine? In 30 days? In six months?
Measured: 15 minutes
Secondary outcomes (1)
Knowledge about ketamine
5 items questionnaire about consequences of using ketamine: micturition, perception distortion, depression, behavioral inhibition and memory
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start19 Aug 2014
- Primary completion19 Mar 2017
- Study completion19 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Szu-Hsien Lee, National Taiwan University
- Investigators
- Tony Szu-Hsien Lee, Ph.D., Principal investigator, Health Promotion and Health Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644719
- Sponsor's protocol ID
- Chronic Ketamine Abusers
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15733250
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief Cognitive and Behavioral Skills Program on Stage Transitions for Chronic Ketamine Abusers
- ClinicalTrials.gov ID
- NCT03644719
- Acronym / sponsor ID
- Chronic Ketamine Abusers
- Conditions
- Substance Use Disorders
- Keywords
- Substance Abuse, Cognitive behavioral treatment, Ketamine, Stage of Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 19 Aug 2014 (actual)
- Primary completion
- 19 Mar 2017 (actual)
- Study completion
- 19 Mar 2017 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior skills training | Experimental | Behavioral: Cognitive behavioral skills trainingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ketamine use in 30 days
- more than 18 years old
Key exclusion criteria (1 listed)
- no brain damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral skills trainingA brief cognitive behavioral skills training was applied to teach ketamine abusers about stimulus control, refusal skills, communication skills, decisional balance, and infectious diseases prevention. | Behavioural | Cognitive behavior skills training |
Primary outcome
Motivation to change
Time frame: 15 minutes
Stage of Change Scale: Have you thought of abstaining from Ketamine? In 30 days? In six months?
1 secondary outcome
Knowledge about ketamine
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Results publication: PubMed 15733250Baker 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Szu-Hsien Lee, Ph.D. principal investigator
Health Promotion and Health Education
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral skills training in people with Substance Use Disorders, run by National Taiwan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation to change (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.