Effect of Extended Cannabis Abstinence on PTSD Symptoms

NCT05162651 | Recruiting

• 1 other identifier: 087-2021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in cognitive function, as measured with various Cambridge Automated Neuropsychological Test Automated Battery (CANTAB) cognitive tests

  Week 0-4

Study Arms (2)

Contingency management group

ACTIVE COMPARATOR

Randomized to receive individual motivational interviewing therapy and contingency management

Behavioral: Contingency-management; Other: Enhanced usual care

Control group

OTHER

Randomized to receive individual motivational interviewing therapy alone

Other: Enhanced usual care

Interventions

Contingency-management 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.

Contingency management group

Enhanced usual care OTHER

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

Contingency management group; Control group

Eligibility Criteria

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

You may qualify if:

• Subjects aged between 18 and 55 years (from both sexes \[or genders\]);
• 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);
• Diagnosis of current (past 30 days) PTSD, using the CAPS-5 on screening;
• On antidepressant medication(s) for at least 1 month (to ensure safety and homogeneity as PTSD treatment of our population);
• Be able to provide written informed consent; and
• Be able to communicate in English.

You may not qualify if:

• diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per the study physician;
• diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder or current acute psychosis or mania based on DSM-5 criteria;
• 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
• have pain interfering with normal function as reported by the 12-Item Short Form Survey (SF-12) (moderate or higher interference).

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: February 2, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

CA (1)