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Cannabis Abstinence for Cannabis Use Disorder

Phase < 1

Recruiting

Led By Stephen R Baldassarri, M.D.

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

A history of seizures/epilepsy

Subjects will be excluded for major medical or neurological illness or laboratories consistent with these illnesses or suggesting contraindication to PET or MR imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and day 28

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore the link between cannabis use disorder, brain activity, and cognitive function to see how they affect each other.

Who is the study for?

This trial is for adults with Cannabis Use Disorder (CUD) who have used cannabis more than 20 times but don't have other substance use disorders or major psychiatric conditions. They must be physically healthy, not pregnant or breastfeeding, and have an IQ over 80. Healthy controls (HC) with no recent cannabis use can also participate.

What is being tested?

The study investigates how stopping cannabis affects brain chemistry, brain waves, and thinking in people with CUD using PET scans to measure a specific receptor and EEG to monitor brain activity. It compares these findings between regular cannabis users and non-users.

What are the potential side effects?

Potential side effects may include discomfort from abstaining from cannabis for those with CUD. The PET scan involves exposure to a small amount of radiation. MRI imaging might cause discomfort due to the enclosed space or noise during the procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures or epilepsy.

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I do not have major medical or neurological illnesses that prevent PET or MR imaging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 28 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 Metabotropic Glutamate Receptor 5 (mGluR5) Availability

Secondary study objectives

Change in Neurocognitive Function using CogState Cognitive Battery

Change in Verbal Memory measured using Electroencephalography (EEG)

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: Healthy controlExperimental Treatment1 Intervention

Healthy control participants undergo neuroimaging, cognitive testing, and EEG at baseline.

Group II: Cannabis use disorderExperimental Treatment2 Interventions

CUD participants participants undergo neuroimaging, cognitive testing, and EEG at baseline and following cannabis abstinence at 4 weeks follow-up. Participants will receive motivational enhancement and contingency management during the 4-week abstinence period.

0 / 2Eligibility criteria met