ArticleContemporary clinical trials2026
Randomized trial of delta-9-tetrahydrocannabinol (THC) versus placebo to augment the effects of prolonged exposure therapy on fear extinction learning in post-traumatic stress disorder: Study rationale and protocol.
Article in Contemporary clinical trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundProlonged exposure (PE) therapy is effective for PTSD, yet dropout and partial response remain concerning. Preclinical and human studies suggest Δ
objectiveExamine whether synthetic THC (dronabinol) augments PE effectiveness.
designDouble-blind, placebo-controlled, trial with treatment-seeking PTSD patients (ages 18-60) randomized to 7.5 mg THC (n = 30) or placebo (n = 30). Randomization after sessions 1-2 (psychoeducation) ensures covariate-adaptive balance before the first medicated session. THC/placebo administered before PE sessions 3-6 of 10 total sessions so dosing coincided with extinction-learning sessions.
settingWayne State University with remote PE delivery via Emory University.
participantsAdults with PTSD (CAPS-5 ≥ 25) excluding for severe mental illness, substance use disorders, or contraindications to THC.
interventionsPE therapy (10 sessions, up to 3 times / week) with THC or placebo administered 120 min before sessions to coincide with peak plasma levels. MAIN OUTCOMES: Primary: PTSD symptom severity (CAPS-5, PCL-5). Secondary: fMRI brain activation during fear extinction paradigms, skin conductance responses, and extinction retention measures pre/post-treatment. STATISTICAL ANALYSIS: Intent-to-treat linear mixed-effects models accounting for therapist clustering. Neuroimaging analyzed via region-of-interest and whole-brain approaches focusing on ventromedial prefrontal cortex, hippocampus, and amygdala. DISCUSSION: THC dosing and timing is based on prior mechanistic studies that demonstrated THC-related enhancement of extinction recall and frontolimbic circuit engagement. Aligning peak THC levels with exposure sessions maximizes potential for CB1-mediated augmentation of extinction learning. If effective, this FDA-approved augmentation strategy could be rapidly implemented to improve PE outcomes.
trial registrationClinicalTrials.govNCT04080427.
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