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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame: weekly (day 0, day 7, day 14, day 21, day 28)]
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 55 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
5%
Transaminases elevated
3%
Accidental CO Poisoning
3%
Pancreatitis
3%
Abnormal EKG
3%
Constipation
3%
ECG Abnormal
100%
80%
60%
40%
20%
0%
Study treatment Arm
3 Placebo + CR
1 Topiramate + CR
2 Topiramate + NonCR
4 Placebo + NonCR

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

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
351 Previous Clinical Trials
80,764 Total Patients Enrolled
Tony P George, MD., FRCPCPrincipal InvestigatorCAMH

Media Library

Contingency Reinforcement Clinical Trial Eligibility Overview. Trial Name: NCT04935619 — N/A
Cognitive Impairment Research Study Groups: Non-Contingency Reinforcement Group, Contingency Reinforcement Group
Cognitive Impairment Clinical Trial 2023: Contingency Reinforcement Highlights & Side Effects. Trial Name: NCT04935619 — N/A
Contingency Reinforcement 2023 Treatment Timeline for Medical Study. Trial Name: NCT04935619 — N/A

Frequently Asked Questions

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

Who has the aptitude to join this investigation?

"To qualify for this trial, participants must have a history of hashish consumption and be within the ages 18-55. This research is looking to enroll 52 individuals in total."

Answered by AI

Are there any vacancies available for individuals to participate in this clinical trial?

"According to clinicaltrials.gov, this trial commencing on July 21st 2021 is actively seeking participants. The most recent update was posted March 7th 2022."

Answered by AI

How extensive is the participation in this trial?

"Confirmed. According to clinicaltrials.gov, the study is open for recruitment and was initially posted on July 21st 2021. Further updates were made in March 7th 2022, with 52 participants being targeted at one site."

Answered by AI

What aims are this inquiry attempting to attain?

"The primary purpose of this research is to measure changes in anhedonia from the start of the trial, over a four-week period. Secondary objectives involve evaluating alterations in attention and visual search using Trail Making Test; sustained attention with Continuous Performance Tests and working memory Digit Span tests."

Answered by AI

Does the criteria for this research encompass elderly participants?

"This trial has stipulated that potential participants should be between the age of 18 and 55. There are 130 studies available for those under 18, while 768 trials exist for senior citizens aged 65 or older."

Answered by AI
~15 spots leftby Apr 2025