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Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD

NCT02759185 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-07-12

Study results available
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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.

Conditions

Interventions

DRUG

High THC cannabis

Three weeks of smoking cannabis containing more THC than CBD with amount smoked limited to no more than 1.8 g per day.

DRUG

High CBD cannabis

Three weeks of smoking cannabis containing more CBD than THC with amount smoked limited to no more than 1.8 g per day.

DRUG

THC/CBD cannabis

Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day.

DRUG

Placebo cannabis

Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day.

Sponsors & Collaborators

  • Multidisciplinary Association for Psychedelic Studies

    lead OTHER

Principal Investigators

  • Sue Sisley, MD · President of Scottsdale Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-02
Primary Completion
2018-11-01
Completion
2019-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02759185 on ClinicalTrials.gov