Recruiting

Cannabis

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT05162651

Conditions

PTSD

Cannabis Use

Cognitive Symptom

Comorbidities and Coexisting Conditions

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Contingency-management

Enhanced usual care

Study Details

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.

Conditions

PTSD

Cannabis Use

Cognitive Symptom

Comorbidities and Coexisting Conditions

Study ID

NCT05162651

Start date

Feb 2, 2022

Status verified date

Apr, 2024

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Contingency management group

Randomized to receive individual motivational interviewing therapy and contingency management

other: Control group

Randomized to receive individual motivational interviewing therapy alone

Interventions

Contingency-management

In addition to structured assessments at baseline, four, eight and twelve months, subjects randomized to the contingency-management group will receive a contingent bonus if the participants show successful abstinence at the end of weeks 4, 8 and 12.

Enhanced usual care

Subjects will receive structured, quantitative assessments at baseline, four, eight and twelve weeks.

Primary outcome measure

  • Severity of PTSD symptoms, as measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 4 [ Time Frame: Week 0-4 ]

Central Contacts and Locations

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M5S 2S1

Contacts

Principal Investigator:

Ahmed Hassan, MD, MPH

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Apr 23, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2024-04-23.