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Behavioral Intervention

Cognitive Behavioral Therapy for Alcoholism and Cannabis Abuse

N/A

Recruiting

Led By Matthew Sloan, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial aims to understand how to tailor treatments for alcohol & cannabis use disorder, by assessing how 3 neurofunctional domains affect response to therapy.

Who is the study for?

This trial is for adults over 18 who have been diagnosed with alcohol use disorder (AUD) or cannabis use disorder (CUD), are willing to participate in group therapy, and can abstain from substances before assessments. They must meet specific criteria for risky drinking or frequent cannabis use. Those unable to communicate in English or unwilling to follow the study's abstinence requirements cannot join.Check my eligibility

What is being tested?

The study tests if assessing three brain functions—executive function, incentive salience, and negative emotionality—before treatment can predict how well people with AUD or CUD respond to therapy. Participants will receive 12 weeks of cognitive behavioral therapy (CBT), with additional pharmacotherapy for AUD if needed.See study design

What are the potential side effects?

Since this trial involves cognitive behavioral therapy and motivational enhancement therapy, there may not be direct side effects like those seen with medications; however, participants might experience emotional discomfort discussing substance use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Amount of Cannabis Used Per Week (grams/week) During Treatment Assessed by the Timeline Followback Interview (TLFB) (CUD group)

Change in Average Drinks Per Day During Treatment Assessed by the Timeline Followback Interview (TLFB) (AUD Group)

Change in Cannabis Use Frequency During Treatment Assessed by the Timeline Followback Interview (TLFB) (CUD group)

+3 more

Secondary outcome measures

Change in Anxiety Symptoms During Treatment Using the Generalized Anxiety Disorder-7 (GAD-7) (AUD and CUD groups)

Change in Depressive Symptoms during Treatment Assessed Using the Patient Health Questionnaire-9 (PHQ-9) (AUD and CUD groups)

Change in Quality of Life During Treatment Assessed Using the Abbreviated World Health Organization Quality of Life Scale (WHOQOL-BREF) (AUD and CUD Groups)

+1 more

Side effects data

From 2009 Phase 2 & 3 trial • 162 Patients • NCT00248612

13%

suicidal ideation

vertigo

agitation/restlessness

nausea

depression

anxiety

profuse sweating

100%

80%

60%

40%

20%

Study treatment Arm

Venlafaxine & CBT

Placebo & CBT

Venlafaxine & PMR

Placebo & PMR

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cannabis Use DisorderExperimental Treatment1 Intervention

Participants will be treated with 12 weeks of CBT + motivational enhancement therapy for CUD (group therapy).

Group II: Alcohol Use DisorderExperimental Treatment1 Intervention

Participants will be treated with 12 weeks of CBT for AUD (group therapy) and have the option to receive evidence-based pharmacotherapy for AUD guided by a pharmacotherapy algorithm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBT

2013

Completed Phase 3

~4220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of OntarioUNKNOWN

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,114 Total Patients Enrolled

5 Trials studying Alcoholism

443 Patients Enrolled for Alcoholism

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,058 Total Patients Enrolled

16 Trials studying Alcoholism

3,105 Patients Enrolled for Alcoholism

Media Library

CBT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05855668 — N/A

Alcoholism Research Study Groups: Cannabis Use Disorder, Alcohol Use Disorder

Alcoholism Clinical Trial 2023: CBT Highlights & Side Effects. Trial Name: NCT05855668 — N/A

CBT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05855668 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for enrollment into this clinical trial?

"Per the information provided on clinicaltrials.gov, this trial is currently searching for test subjects. The original posting date was November 10th 2022 and it has been modified as recently as May 4th 2023."

Answered by AI

What is the total enrollment of participants in this clinical trial?

"Affirmative. According to records stored on clinicaltrials.gov, this research trial has been actively recruiting since November 10th 2022 and was recently updated on May 4th 2023. 400 participants are needed from one site in total for the study's completion."

Answered by AI

What objectives are the investigators hoping to attain from this medical experiment?

"The primary endpoint to be measured over a 12 weeks period is the alteration in self-reported alcohol craving, as determined by the Penn Alcohol Craving Scale. Other outcomes of interest include any changes in depressive symptoms using the Patient Health Questionnaire-9, Quality of Life with the Abbreviated World Health Organization Quality of Life scale and retention rate within treatment defined as those that complete at least 4 sessions or 33% of available treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

2022. "Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05855668.

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