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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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