Reduce THC Use
Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity
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This study is looking at therapeutic potential of reducing Tetrahydrocannabinol (THC) levels in regular cannabis smokers using contingency management (CM) intervention in a U.S. veteran population with post-traumatic stress disorder (PTSD).
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2024-05-03
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
In this trial, the investigators will recruit veterans with post-traumatic stress disorder (PTSD) who report using cannabis. Veterans will be assigned (via participant self-selection) into either a naturalistic group that will be followed as the participants continue to use cannabis as they normally do (observation only), or into a "THC (tetrahydrocannabinol) reduction group" in which veterans are asked to switch from their typical cannabis product to using a lower THC/higher Cannabidiol (CBD) product; adherence to this switch will be incentivized using a behavioral intervention called contingency management (CM).
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity
Eligibility
primary outcomes
Time frame: Baseline, 3, 6, 12 months post baseline
Assessing change in PTSD symptom severity from baseline, to 3, 6, and 12 months post baseline. A decrease in the CAPS-5 assessment indicates less PTSD symptoms endorsed and a better outcome. Minimum score is 0, maximum score is 20 for PTSD subtotals.
Time frame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Assessing change in PTSD symptom and severity over time. This scale is completed by the participants and a lower score indicates less PTSD symptoms and better study outcomes. Maximum score is 80 and minimum score is 20.
Time frame: Baseline, 3, 6, 12 months post baseline
Suicide ideation, intensity, and behavior assessment. This is a clinical interview to assess suicide severity. Reduction in suicide related behaviors represents a better study outcome.
Time frame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Suicide ideation, intensity, and behavior assessment completed by participants. Scores range from 3 to 18, with lower score representing better study outcome.
secondary outcomes
Time frame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Self report depression checklist. Beck Depression Inventory-II scores range from 0 to 63 and lower score represent better outcome.
Time frame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Anxiety symptom checklists ranging from from 20 to 80. Lower scores on this measures represents better study outcome.
Time frame: Baseline, 3, 6, 12 months post baseline
Verbal memory task that will be used to measure the change in executive function over time.
Time frame: Baseline, 3, 6, 12 months post baseline
Computer task that will be used to measure the change in executive function over time.
Time frame: Baseline, 3, 6, 12 months post baseline
Computer task that measure the change in decision making over time.
Time frame: Baseline, 3, 6, 12 months post baseline
General health questionnaire to assess change in general health outcomes over time. General health survey is scored from 0 to 100 with a higher score denoting better study outcomes.
Time frame: Baseline, 3, 6, 12 months post baseline
Quality of Life assessment to examine change in quality of life over time. Quality of life inventory is scored from 16 to 112, higher score indicating better study outcome.
Time frame: Baseline, 3, 6, 12 months post baseline
Brief pain inventory asks participants identify areas on their body causing pain and rate the severity. Less pain symptoms over time represent a better study outcome.
Time frame: Baseline
DNA analysis to examine genetic markers associated with the endocannabinoid system. The genetic data will be collected from blood samples during baseline. Data will be grouped based on genetic variants of proteins within the endocannabinoid system to identify genetic differences in response to the treatment trial.
Publications