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Nabilone in Cannabis Users With PTSD

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ClinicalTrials.gov Identifier: NCT03251326
Recruitment Status : Active, not recruiting
First Posted : August 16, 2017
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Margaret Haney, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE August 14, 2017
First Posted Date  ICMJE August 16, 2017
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE October 2015
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
Cue Reactivity [ Time Frame: 1 month ]
Emotional Stroop Task
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03251326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nabilone in Cannabis Users With PTSD
Official Title  ICMJE Effects 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Cannabis
  • Post Traumatic Stress Disorder
Intervention  ICMJE
  • Drug: Nabilone
    Nabilone capsules (4 mg)
  • Drug: Cannabis
    Cigarettes (0.0 and 5.6% THC)
  • Drug: Propranolol
    Propranolol capsules (40mg)
  • Drug: Placebo
    Placebo capsules
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2018)
2
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2017)
14
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03251326
Other Study ID Numbers  ICMJE 6971
U54DA037842 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Margaret Haney, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account New York State Psychiatric Institute
Verification Date December 2018

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