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NCT03251326 Clinical Trial

Nabilone in Cannabis Users With PTSD

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03251326
Other study ID # 6971
Secondary ID U54DA037842
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date October 2015
Est. completion date June 2019

Study information
Verified date June 2022
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nabilone
Nabilone capsules (4 mg)
• Cannabis
Cigarettes (0.0 and 5.6% THC)
• Propranolol
Propranolol capsules (40mg)
• Placebo
Placebo capsules

Locations
Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)
Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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