Effect of Extended Cannabis Abstinence on PTSD Symptoms

NCT ID: NCT05162651

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2024-09-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Contingency management group

Randomized to receive individual motivational interviewing therapy and contingency management

Group Type: ACTIVE_COMPARATOR

Contingency-management

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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

Control group

Randomized to receive individual motivational interviewing therapy alone

Group Type: OTHER

Enhanced usual care

Intervention Type: OTHER

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

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.

Intervention Type: BEHAVIORAL

Enhanced usual care

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Ahmed N Hassan

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Ahmed Hassan, MD, MPH

Role: primary

ahmed.hassan@camh.ca

416-535-8501 ext. 34051

Abigail Amartey, MPH

Role: backup

abigail.amartey@camh.ca

416-535-8501 ext. 33651

Other Identifiers

087-2021

Identifier Type: -

Identifier Source: org_study_id