NCT03251326

Nabilone in Cannabis Users With PTSD

Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.

Detailed description

This study will compare the effects of smoked cannabis and nabilone on attentional bias toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and non-trauma-related images and physiological reactivity to these stimuli in individuals with CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone compared to smoked cannabis in this population, a critical aspect in determining the potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of nabilone will be compared to propranolol as a positive control.

Conditions

• Cannabis
• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Nabilone	Nabilone capsules (4 mg)
DRUG	Cannabis	Cigarettes (0.0 and 5.6% THC)
DRUG	Propranolol	Propranolol capsules (40mg)
DRUG	Placebo	Placebo capsules

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2017-08-16
• Last updated: 2022-07-15
• Results posted: 2020-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study