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Nabilone in Cannabis Users With PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03251326
Recruitment Status : Active, not recruiting
First Posted : August 16, 2017
Last Update Posted : December 6, 2018
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Margaret Haney, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Cannabis Post Traumatic Stress Disorder Drug: Nabilone Drug: Cannabis Drug: Propranolol Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
Actual Study Start Date : October 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Nabilone

Arm Intervention/treatment
Experimental: Nabilone
Nabilone capsules (4 mg)
Drug: Nabilone
Nabilone capsules (4 mg)

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)

Placebo Comparator: Placebo
Placebo capsules
Drug: Placebo
Placebo capsules

Primary Outcome Measures :
  1. Cue Reactivity [ Time Frame: 1 month ]
    Emotional Stroop Task

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03251326

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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)

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Responsible Party: Margaret Haney, Professor of Neurobiology (in Psychiatry) at CUMC, New York State Psychiatric Institute Identifier: NCT03251326     History of Changes
Other Study ID Numbers: 6971
U54DA037842 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Marijuana Abuse
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic