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Effects of Cannabis Abstinence on Symptoms and Cognition in Depression

C

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Major Depressive Disorder
Cannabis Use Disorder
Cognition

Treatments

Behavioral: Weekly Behavioral Coaching Session
Behavioral: Contingency Management

Study type

Interventional

Funder types

Other

Identifiers

NCT03624933
069/2017

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

28-Day Cannabis Abstinence
Experimental group
Description:
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.
Treatment:
Behavioral: Contingency Management
Behavioral: Weekly Behavioral Coaching Session

Trial contacts and locations

1

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Central trial contact

Aliya Lucatch, BSc; Julia Sasiadek, BA

Data sourced from clinicaltrials.gov

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