Effects of Cannabis Abstinence on Symptoms and Cognition in Depression

NCT03624933 | Completed DMC

• 1 other identifier: 069/2017
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Use Disorder; Major Depressive Disorder; Cognition

Keywords

Depression; Cognitive Functioning; Cannabis Use Disorder

Outcome Measures

Primary Outcomes (1)

• The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with Major Depressive Disorder (MDD) as assessed by the Hamilton Rating Scale for Depression (HRSD).

  The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel. The HRDS is used to evaluate depression on a 17-item scale with higher values indicating worse depressive symptoms.

  Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)

Secondary Outcomes (2)

• The effects of 28 day cannabis abstinence on change in cognitive function in cannabis dependent patients with Major Depressive Disorder (MDD) as assessed by a cognitive battery administered at Baseline, Week 2, Endpoint and Follow-Up.

  Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56)

• The effects of 28 day cannabis abstinence on change in co-occurring anxiety in cannabis dependent patients with MDD as assessed by the Beck Anxiety Inventory (BAI) administered weekly.

  Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)

Study Arms (1)

28-Day Cannabis Abstinence

EXPERIMENTAL

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.

Behavioral: Weekly Behavioral Coaching Session; Behavioral: Contingency Management

Interventions

Weekly Behavioral Coaching Session 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.

28-Day Cannabis Abstinence

Contingency Management 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.

28-Day Cannabis Abstinence

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (1)

• Sorkhou M, Rabin RA, Rabin JS, Kloiber S, McIntyre RS, George TP. Effects of 28 days of cannabis abstinence on cognition in major depressive disorder: A pilot study. Am J Addict. 2022 Sep;31(5):454-462. doi: 10.1111/ajad.13305. Epub 2022 Jun 11.

  PMID: 35690891 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Tony George, M.D., FRCPC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Addictions Division

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 10, 2018
• Study Start: November 6, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

CA (1)