Nabilone in Cannabis Users With PTSD

ID: NCT03251326
Status: Recruiting
Phase: Phase 1/Phase 2
Start Date: October 01, 2015
First Submitted: August 14, 2017
Last Updated: August 14, 2017
Results: N/A
Sponsors & Collaborators: New York State Psychiatric Institute, National Institute on Drug Abuse (NIDA)
Location: United States
Conditions: Cannabis, Post Traumatic Stress Disorder
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Study Description

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.
Condition or disease Intervention/treatment Phase

Cannabis

Post Traumatic Stress Disorder

Drug: Nabilone
Other Names
Drug: Cannabis
Other Names
Drug: Propranolol
Other Names
Drug: Placebo
Other Names
Phase 1/Phase 2

Tracking Information

First Submitted DateAugust 14, 2017
Last Update Posted DateAugust 14, 2017
Actual Start DateOctober 01, 2015
Anticipated Completion DateAugust 01, 2019
Actual Primary Completion DateAugust 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Cue Reactivity [Time Frame: 1 month]

    Emotional Stroop Task

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleNabilone in Cannabis Users With PTSD
Official TitleEffects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
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.

Study TypeInterventional
Study PhasePhase 1/Phase 2
Estimated Enrollment
14
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Primary Purpose
Basic Science
Conditions
Cannabis
Post Traumatic Stress Disorder
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Nabilone

Nabilone capsules (4 mg)

Other Names
Drug: Cannabis

Cigarettes (0.0 and 5.6% THC)

Other Names
Drug: Propranolol

Propranolol capsules (40mg)

Other Names
Drug: Placebo

Placebo capsules

Other Names
Study Groups/Cohorts
Nabilone
Nabilone capsules (4 mg)

Propranolol
Propranolol capsules (40mg)

Smoked cannabis
(0.0 and 5.6% THC)

Placebo
Placebo capsules

Study Arms
Experimental Nabilone
Nabilone capsules (4 mg)
Drug : Nabilone
Nabilone capsules (4 mg)

Placebo Comparator Placebo
Placebo capsules
Drug : Placebo
Placebo capsules

Active Comparator Propranolol
Propranolol capsules (40mg)
Drug : Propranolol
Propranolol capsules (40mg)

Experimental Smoked cannabis
(0.0 and 5.6% THC)
Drug : Cannabis
Cigarettes (0.0 and 5.6% THC)

Arm Intervention/Treatment
Experimental Nabilone
Nabilone capsules (4 mg)
Drug : Nabilone
Placebo Comparator Placebo
Placebo capsules
Drug : Placebo
Active Comparator Propranolol
Propranolol capsules (40mg)
Drug : Propranolol
Experimental Smoked cannabis
(0.0 and 5.6% THC)
Drug : Cannabis

Recruitment Information

Recruitment Status:Recruiting
Enrollment14
Completion DateAugust 01, 2019
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
GenderAll
Age21 Years to 45 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03251326
Other Study ID Numbers
6971
U54DA037842
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Not Available