Nabilone in Cannabis Users With PTSD

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Cannabis, Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: Nabilone
* Drug: Cannabis
* Drug: Propranolol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current cannabis use PTSD symptoms Able to give informed consent and comply with study procedures Women who are normally cycling and practicing an effective form of birth control other than hormonal contraceptives Exclusion Criteria: Meeting criteria for certain current psychiatric disorders Clinical laboratory tests outside of normal limits History of clinically significant cardiac or respiratory diagnoses Current parole or probation Women who are currently pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nabilone<br>Nabilone capsules (4 mg) | Drug: Nabilone<br>* Nabilone capsules (4 mg)<br>|
| Active Comparator: Propranolol<br>Propranolol capsules (40mg) | Drug: Propranolol<br>* Propranolol capsules (40mg)<br>|
| Experimental: Smoked cannabis<br>(0.0 and 5.6% THC) | Drug: Cannabis<br>* Cigarettes (0.0 and 5.6% THC)<br>|
| Placebo Comparator: Placebo<br>Placebo capsules | Drug: Placebo<br>* Placebo capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cue Reactivity (Emotional Stroop Task) | We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data. | 1 month |