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Effect of Extended Cannabis Abstinence on PTSD Symptoms (CANPOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05162651
Recruitment Status : Recruiting
First Posted : December 17, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmed N Hassan, 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.

Condition or disease Intervention/treatment Phase
PTSD Cannabis Use Cognitive Symptom Comorbidities and Coexisting Conditions Behavioral: Contingency-management Other: Enhanced usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Extended Cannabis Abstinence on PTSD Symptoms
Estimated Study Start Date : January 2, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Contingency management group
Randomized to receive individual motivational interviewing therapy and contingency management
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.

Control group
Randomized to receive individual motivational interviewing therapy alone
Other: Enhanced usual care
Subjects will receive structured, quantitative assessments at baseline, four, eight and twelve weeks.




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Changes in cognitive function, as measured with various Cambridge Automated Neuropsychological Test Automated Battery (CANTAB) cognitive tests [ Time Frame: Week 0-4 ]
    Changes between abstainers and non-abstainers on cognitive testing during the study phase.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05162651


Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5S 2S1
Contact: Ahmed Hassan, MD, MPH    416-535-8501 ext 34051    ahmed.hassan@camh.ca   
Contact: Abigail Amartey, MPH    416-535-8501 ext 33651    abigail.amartey@camh.ca   
Principal Investigator: Ahmed Hassan, MD, MPH         
Sponsors and Collaborators
Centre for Addiction and Mental Health
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Responsible Party: Ahmed N Hassan, Doctor, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT05162651    
Other Study ID Numbers: 087-2021
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases