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The objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and Bipolar (Type I or II) disorder. Stabilized bipolar patients (N=52) with CUD will be randomly assigned to one of two groups: 1) A contingent reinforcement (CR) group (n=26); 2) a non-contingent reinforcement (NCR) group (n=26). The study will include a total of 8 visits to the CAMH Russell site (screening, training, baselines, week 1-4, follow-up). Participants should be between the ages of 18-60, meet criteria for CUD (moderate to severe), meet criteria for Bipolar Disorder, be on a stable dose of mood stabilizing medication(s), and be non-treatment seeking cannabis user. The visits will take up a total of approximately 22.5 hours with compensation for time provided for both groups. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement for the CR group.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-09-11
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This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
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Interventions
The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.
Eligibility
primary outcomes
Time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel.
Time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel.
secondary outcomes
Time frame: Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56)
The cognitive battery will include the primary outcome of motivation and effort (assessed by TOMM) and will be compared to baseline (Day 1) performance. Cortical inhibition will also be assessed and compared.
Time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
The clinical assessment will be administered at Baseline, weekly during the abstinence period and Follow-up and will be conducted by study personnel.
Publications
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