Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD
Condition: Posttraumatic Stress Disorder
MeSH terms: Marijuana Abuse; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: High THC cannabis; High CBD cannabis; THC/CBD cannabis; Placebo cannabis
Intervention description: Three weeks of smoking cannabis containing more THC than CBD with amount smoked limited to no more than 1.8 g per day.; Three weeks of smoking cannabis containing more CBD than THC with amount smoked limited to no more than 1.8 g per day.; Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day.; Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day.
Intervention MeSH terms: Dronabinol; Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTSD; marijuana; cannabis; sleep; THC; CBD

Summary:

      This pilot study gathered preliminary evidence of the safety and efficacy of four potencies
      of smoked cannabis to manage chronic, treatment-resistant PTSD among veterans: (1) High THC/
      Low CBD (High THC), (2) Low THC/High CBD (High CBD), (3) High THC/ High CBD (THC/CBD) and (4)
      Low THC/Low CBD (placebo). The study will produce preliminary evidence to help elucidate the
      potential effects of THC, CBD, or a combination of both constituents to reduce PTSD symptoms.
      Smoked cannabis will be tested in two stages of three weeks each (Stage 1 and Stage 2), with
      a two-week cessation period after each stage, verified by blood/urine cannabinoid analysis.
      The primary objective was to compare three active concentrations of smoked cannabis and
      placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have chronic treatment-resistant PTSD of at least six months duration.

          -  Have PTSD of at least moderate severity at the time of baseline assessment.

          -  Be a military veteran with PTSD.

          -  Be at least 18 years old.

          -  Be willing to commit to medication dosing and delivery method, to completing
             evaluation instruments, and attending all study visits.

          -  Agree to use only cannabis provided by site staff and agree to required cessation
             periods for the duration of the study.

          -  Report no current hazardous cannabis use and completely abstain from cannabis during
             the 2-week baseline assessment period (verified via urine and/or blood cannabinoid
             concentrations).

          -  Agree to video record all cannabis administrations and provide video to the site staff
             for review during study participation.

          -  Agree to keep all cannabis provided by site staff securely stored in the provided lock
             box and not to share/distribute cannabis to any other individual.

          -  Be stable on any pre-study medications and/or psychotherapy regimen for PTSD prior to
             study entry, agree to notify their physician/clinician about participation in the
             study, and agree to report any changes in medication or psychotherapy treatment
             regimen during the study, to site staff.

          -  If female and of childbearing potential, agree to use an effective form of birth
             control during study participation and may only be allowed to enroll and continue in
             the study based on a negative pregnancy test.

          -  Be proficient in reading and writing in English and able to effectively communicate
             with site staff.

          -  Agree not to participate in any other interventional clinical trials during the study

        Exclusion Criteria:

          -  Upon review of medical or psychiatric history must not have any current or past
             diagnosis that would be considered a risk to participation in the study.

          -  Have any allergies to cannabis or contraindication for smoking of cannabis

          -  Are abusing illegal drugs.

          -  Are not able to give adequate informed consent.

          -  Are not able to attend face-to-face visits or those who plan to move out of the area
             within the treatment period.

          -  Are pregnant or nursing, or if a woman who can have children, those who are not
             practicing an effective means of birth control.