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Trial record 41 of 151 for:    cannabis | Recruiting, Enrolling by invitation Studies

Nabilone in Cannabis Users With PTSD

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ClinicalTrials.gov Identifier: NCT03251326
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

August 14, 2017
August 16, 2017
August 16, 2018
October 2015
August 2019   (Final data collection date for primary outcome measure)
Cue Reactivity [ Time Frame: 1 month ]
Emotional Stroop Task
Same as current
Complete list of historical versions of study NCT03251326 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nabilone in Cannabis Users With PTSD
Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
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.
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.
Interventional
Phase 1
Phase 2
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
  • Cannabis
  • Post Traumatic Stress Disorder
  • Drug: Nabilone
    Nabilone capsules (4 mg)
  • Drug: Cannabis
    Cigarettes (0.0 and 5.6% THC)
  • Drug: Propranolol
    Propranolol capsules (40mg)
  • Drug: Placebo
    Placebo capsules
  • Experimental: Nabilone
    Nabilone capsules (4 mg)
    Intervention: Drug: Nabilone
  • Active Comparator: Propranolol
    Propranolol capsules (40mg)
    Intervention: Drug: Propranolol
  • Experimental: Smoked cannabis
    (0.0 and 5.6% THC)
    Intervention: Drug: Cannabis
  • Placebo Comparator: Placebo
    Placebo capsules
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14
Same as current
August 2019
August 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 45 Years   (Adult)
No
Contact: Margaret Haney, PhD 6467746129 meg.haney@nyspi.columbia.edu
United States
 
 
NCT03251326
6971
U54DA037842 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Not Provided
New York State Psychiatric Institute
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP