Effect of Extended Cannabis Abstinence on PTSD Symptoms

PTSD Clinical Trial

— CANPOST  

Official title:

Effect of Extended Cannabis Abstinence on PTSD Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05162651
• Other study ID #: 087-2021
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cannabis Use
• Cognitive Symptom
• Comorbidities and Coexisting Conditions
• Marijuana Abuse
• Neurobehavioral Manifestations
• PTSD

Intervention

Behavioral:
• 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.

Other:
• Enhanced usual care
Subjects will receive structured, quantitative assessments at baseline, four, eight and twelve weeks.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of PTSD symptoms, as measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 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.	Week 0-4
Secondary	Changes in cognitive function, as measured with various Cambridge Automated Neuropsychological Test Automated Battery (CANTAB) cognitive tests	Changes between abstainers and non-abstainers on cognitive testing during the study phase.	Week 0-4