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Cannabis Abstinence for Depression

N/A

Recruiting

Led By Tony P George, MD., FRCPC

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

Participants must be between the ages 18-55

Be between 18 and 65 years old

Must not have

Participants with a head injury lasting more than 5 minutes with loss of consciousness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up [time frame: weekly (day 0, day 7, day 14, day 21, day 28)]

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates the effects of cannabis abstinence over a 28-day period in patients with MDD with co-occurring CUD using a randomized controlled design, namely contingent reinforcement.

Who is the study for?

This trial is for adults aged 18-55 with Major Depressive Disorder and co-occurring moderate to severe Cannabis Use Disorder. They must be on stable antidepressant medication for three months, have an IQ of 80 or above, and show motivation. Excluded are those with bipolar disorder, significant head injury, other substance abuse (except nicotine/caffeine), psychotic disorders, or current suicidal/homicidal thoughts.

What is being tested?

The study examines the impact of stopping cannabis use for 28 days in patients with depression who also frequently use cannabis. Participants will either receive rewards for abstaining from cannabis (Contingency Reinforcement) or not (Non-Contingency Reinforcement), to see if this affects their depression symptoms and cognitive function.

What are the potential side effects?

Potential side effects may include withdrawal symptoms such as irritability, mood swings, sleep difficulties, decreased appetite, restlessness, cravings for cannabis; as well as possible changes in depressive symptoms due to abstinence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

Exclusion Criteria

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

Select...

I had a head injury that made me unconscious for over 5 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ [time frame: weekly (day 0, day 7, day 14, day 21, day 28)]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~[time frame: weekly (day 0, day 7, day 14, day 21, day 28)]

This trial's timeline: 3 weeks for screening, Varies for treatment, and [time frame: weekly (day 0, day 7, day 14, day 21, 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

Changes in Anhedonia from Baseline to Week 4

Changes in Anxious Symptomology from Baseline to Week 4

Changes in Depressive Symptomology from Baseline to Week 4

+1 more

Secondary study objectives

Changes in Attention and Visual Search

Changes in Sustained Attention

Changes in Verbal Learning and Memory

+1 more

Side effects data

From 2011 Phase 2 trial • 250 Patients • NCT00685178

Transaminases elevated

Pancreatitis

Abnormal EKG

Accidental CO Poisoning

Constipation

ECG Abnormal

100%

80%

60%

40%

20%

Study treatment Arm

3 Placebo + CR

1 Topiramate + CR

2 Topiramate + NonCR

4 Placebo + NonCR

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: Non-Contingency Reinforcement GroupExperimental Treatment1 Intervention

Subjects assigned to the NCR group with self-reported abstinence verified by urinary THC-COOH level \<20 ng/ml will not receive contingency monetary reinforcement at Day 28 of the study.

Group II: Contingency Reinforcement GroupExperimental Treatment1 Intervention

Subjects assigned to the CR group with self-reported abstinence verified by urinary THC-COOH level \<20 ng/ml will receive contingency monetary reinforcement at Day 28 of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contingency Reinforcement

2007

Completed Phase 2

~250

0 / 2Eligibility criteria met