Back to resultsEffect of Extended Cannabis Abstinence on PTSD Symptoms (CANPOST)
Primary Purpose
PTSD, Cannabis Use, Cognitive Symptom
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Contingency-management
Enhanced usual care
Sponsored by
About this trial
This is an interventional other trial for PTSD
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Centre for Addiction and Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Contingency management group
Control group
Arm Description
Randomized to receive individual motivational interviewing therapy and contingency management
Randomized to receive individual motivational interviewing therapy alone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05162651
First Posted
December 6, 2021
Last Updated
January 10, 2023
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT05162651
Brief Title
Effect of Extended Cannabis Abstinence on PTSD Symptoms
Acronym
CANPOST
Official Title
Effect of Extended Cannabis Abstinence on PTSD Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Cannabis Use, Cognitive Symptom, Comorbidities and Coexisting Conditions
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contingency management group
Arm Type
Active Comparator
Arm Description
Randomized to receive individual motivational interviewing therapy and contingency management
Arm Title
Control group
Arm Type
Other
Arm Description
Randomized to receive individual motivational interviewing therapy alone
Intervention Type
Behavioral
Intervention Name(s)
Contingency-management
Intervention Description
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
Other
Intervention Name(s)
Enhanced usual care
Intervention Description
Subjects will receive structured, quantitative assessments at baseline, four, eight and twelve weeks.
Primary Outcome Measure Information:
Title
Severity of PTSD symptoms, as measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 4
Description
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.
Time Frame
Week 0-4
Secondary Outcome Measure Information:
Title
Changes in cognitive function, as measured with various Cambridge Automated Neuropsychological Test Automated Battery (CANTAB) cognitive tests
Description
Changes between abstainers and non-abstainers on cognitive testing during the study phase.
Time Frame
Week 0-4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Hassan, MD, MPH
Phone
416-535-8501
Ext
34051
Email
ahmed.hassan@camh.ca
First Name & Middle Initial & Last Name & Degree
Abigail Amartey, MPH
Phone
416-535-8501
Ext
33651
Email
abigail.amartey@camh.ca
First Name & Middle Initial & Last Name & Degree
Ahmed Hassan, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Extended Cannabis Abstinence on PTSD Symptoms
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