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Preliminary, open-label, pilot study of add-on oral Δ9-tetrahydrocannabinol in chronic post-traumatic stress disorder.

Pablo Roitman, Raphael Mechoulam, Rena Cooper-Kazaz, Arieh Shalev

Clinical drug investigation August 2014 DOI: 10.1007/s40261-014-0212-3 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Open-label study Pilot study Peer reviewed
Sample size 10
Population Outpatients with chronic PTSD on stable medication
Dose 5 mg twice a day
Topics Cannabis PTSD
Key points In 10 outpatients with chronic PTSD, add-on oral delta-9-THC at 5 mg twice daily produced statistically significant improvements in global symptom severity, sleep quality, nightmare frequency, and hyperarousal symptoms, with only mild adverse effects in three patients and no discontinuations. The authors conclude that oral THC was safe and well tolerated in this population.

Abstract

Many patients with post-traumatic stress disorder (PTSD) achieve but partial remission with current treatments. Patients with unremitted PTSD show high rates of substance abuse. Marijuana is often used as compassion add-on therapy for treatment-resistant PTSD. This open-label study evaluates the tolerance and safety of orally absorbable Δ(9)-tetrahydrocannabinol (THC) for chronic PTSD. Ten outpatients with chronic PTSD, on stable medication, received 5 mg of Δ(9)-THC twice a day as add-on treatment. There were mild adverse effects in three patients, none of which led to treatment discontinuation. The intervention caused a statistically significant improvement in global symptom severity, sleep quality, frequency of nightmares, and PTSD hyperarousal symptoms. Orally absorbable Δ(9)-THC was safe and well tolerated by patients with chronic PTSD.

Comparable studies

Other non-randomized and open-label trials on PTSD, most cited first.

Study Year Design Participants
Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Adults with chronic, treatment-resistant PTSD 2013 Long-term follow-up of a completed trial n = 19
Loving‐Kindness Meditation for Posttraumatic Stress Disorder: A Pilot Study Veterans with posttraumatic stress disorder (PTSD) 2013 Open pilot trial
Effects of Transcendental Meditation in Veterans of Operation Enduring Freedom and Operation Iraqi Freedom With Posttraumatic Stress Disorder: A Pilot Study Veterans from Operation Enduring Freedom or Operation Iraqi Freedom with combat-related... 2011 Uncontrolled pilot study n = 5
MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial. Couples in which one partner was diagnosed with PTSD 2020 Pilot study n = 6
Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder People of color with posttraumatic stress disorder 2019 Phase 2 open-label multisite study

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