Effect of Extended Cannabis Abstinence on PTSD Symptoms

Not Applicable

Recruiting

• Conditions: Cannabis Use; Cognitive Symptom; PTSD; Comorbidities and Coexisting Conditions
• Interventions: Behavioral: Contingency-management; Other: Enhanced usual care

• Registration Number: NCT05162651
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

This will be a 12-week randomized trial. Outpatients and patients from the Mood and Anxiety program at the Centre for Addiction and Mental Health (CAMH) with a current diagnosis of post-traumatic stressed disorder (PTSD) and cannabis-use disorder (CUD) will be randomized to receive individual motivational interviewing therapy and contingency management (n = 12) or individual motivational interviewing therapy alone (control group, n = 12) after enrolment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-17
• Study Start: 2022-02-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Subjects aged between 18 and 55 years (from both sexes [or genders]);
2. Diagnosed with CUD (moderate or severe) according to the Structured Clinical Interview for DSM-IV (SCID) (mode of cannabis consumption can be inhalation or ingestion);
3. Diagnosis of current (past 30 days) PTSD, using the CAPS-5 on screening;
4. On antidepressant medication(s) for at least 1 month (to ensure safety and homogeneity as PTSD treatment of our population);
5. Be able to provide written informed consent; and
6. Be able to communicate in English.

Exclusion Criteria

1. diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per the study physician;
2. diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder or current acute psychosis or mania based on DSM-5 criteria;
3. current suicidality risk as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after the study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes" 34; and
4. have pain interfering with normal function as reported by the 12-Item Short Form Survey (SF-12) (moderate or higher interference).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contingency management group	Enhanced usual care	Randomized to receive individual motivational interviewing therapy and contingency management
Contingency management group	Contingency-management	Randomized to receive individual motivational interviewing therapy and contingency management
Control group	Enhanced usual care	Randomized to receive individual motivational interviewing therapy alone

Primary Outcome Measures

Name	Time	Method
Severity of PTSD symptoms, as measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 4	Week 0-4	Changes in CAPS-5 during the study phase between the group that achieved abstinence and the group that did not. In addition, we will record changes in each PTSD symptom category, which will all be part of the larger trial analysis.

Secondary Outcome Measures

Name	Time	Method
Changes in cognitive function, as measured with various Cambridge Automated Neuropsychological Test Automated Battery (CANTAB) cognitive tests	Week 0-4	Changes between abstainers and non-abstainers on cognitive testing during the study phase.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada