Effects of Cannabis Abstinence on Symptoms and Cognition in Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2019-12-30

Brief Summary

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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 Major Depression (MDD). This study employs a 28-day abstinence paradigm a total of 8 visits to the CAMH Russell site (screening, training, baseline, week 1, week 2, week 3, week 4, follow-up). Participants should be between the ages of 18-55, meet criteria for moderate depression and CUD, be non-treatment seeking, and be on a stable dose of antidepressant medication. The study visits will take up a total of approximately 22.5 hours with compensation for time provided. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement.

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Detailed Description

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Conditions

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Cannabis Use Disorder Major Depressive Disorder Cognition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an open label intervention of contingent reinforcement and behavioral support to try to enhance cannabis abstinence for 28 days with people with Major Depressive Disorder. We will analyze data post hoc from this study as a function of subjects who attain abstinence versus those who do not.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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28-Day Cannabis Abstinence

The study will assess the changes that occur after a 28-day abstinence period in patients with Major Depressive Disorder (MDD) and comorbid Cannabis Use Disorder (CUD). Patients will be instructed to initiate abstinence 12 hours prior to the baseline session and will come in for weekly visits involving a series of clinical, cognitive, and substance use assessments.

Group Type EXPERIMENTAL

Weekly Behavioral Coaching Session

Intervention Type BEHAVIORAL

The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days of abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.

Contingency Management

Intervention Type BEHAVIORAL

If the participant's weekly abstinence is successful as determined by the urine results on day 28, the participant will receive an additional $300.00 cash bonus on top of their hourly $10 compensation for attending all visits. We predict that this cash bonus is enough incentive to allow for the behavioural change of abstinence in this patient population.

Interventions

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Weekly Behavioral Coaching Session

The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days of abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.

Intervention Type BEHAVIORAL

Contingency Management

If the participant's weekly abstinence is successful as determined by the urine results on day 28, the participant will receive an additional $300.00 cash bonus on top of their hourly $10 compensation for attending all visits. We predict that this cash bonus is enough incentive to allow for the behavioural change of abstinence in this patient population.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* ages 18-55
* meet DSM-5 diagnostic criteria for cannabis use disorder (cannabis use \>1 g/day, CUDIT score \>12)
* meet DSM-5 diagnostic criteria for Major Depressive Disorder as determined using the SCID
* be an outpatient receiving a stable dose of antidepressant medication(s) for at least 1 month
* have a Hamilton Depression Rating Scale (HDRS-17) baseline total score greater than 14
* have a Full Scale IQ greater than 80 as determined by the WTAR
* be a non-treatment seeking cannabis user
* evidence of sufficient motivation and effort as measure by a Test of Memory Malingering (TOMM) score greater than 45
* urinary baseline THC-COOH levels greater than 150 ng/ml

Exclusion Criteria

* meets criteria for abuse or dependence of alcohol or other illicit substances within the part 6 months (with the exception of cannabis, nicotine, or caffeine)
* positive urine screen for illicit substances other than cannabis, nicotine or caffeine
* current suicidal or homicidal ideation
* psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
* head injury with loss of consciousness greater than 2 minutes or requiring hospitalization
* neurological or medical condition determined to effect cognition
* be treatment seeking for cannabis use

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No