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Study of Four Different Potencies of Smoked Marijuana in 76 Veterans With Chronic, Treatment-Resistant PTSD

This study is currently recruiting participants.
Verified September 2017 by Multidisciplinary Association for Psychedelic Studies
Sponsor:
ClinicalTrials.gov Identifier:
NCT02759185
First Posted: May 3, 2016
Last Update Posted: September 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
April 29, 2016
May 3, 2016
September 25, 2017
January 2, 2017
August 2018   (Final data collection date for primary outcome measure)
Change in CAPS Global Severity Score from baseline to primary endpoint [ Time Frame: Baseline, 3 weeks after randomization ]
Clinician-Administered PTSD Scale, a measure of PTSD symptom severity
  • Change in CAPS Global Severity Score from baseline to primary endpoint [ Time Frame: Baseline, 3 weeks after randomization ]
    Clinician-Administered PTSD Scale, a measure of PTSD symptom severity
  • Change in CAPS Global Severity Score from baseline to secondary endpoint [ Time Frame: Baseline and eight weeks after study randomization ]
    Clinician-Administered PTSD Scale, measure of PTSD symptoms
Complete list of historical versions of study NCT02759185 on ClinicalTrials.gov Archive Site
Change in CAPS Global Severity Score from baseline to secondary endpoint [ Time Frame: Baseline and eight weeks after study randomization ]
Clinician-Administered PTSD Scale, a measure of PTSD symptom severity
Not Provided
Not Provided
Not Provided
 
Study of Four Different Potencies of Smoked Marijuana in 76 Veterans With Chronic, Treatment-Resistant PTSD
Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
Posttraumatic stress disorder (PTSD) is a debilitating disorder experienced by a subset of individuals following life-threatening trauma, such as sexual and physical assault, natural disasters, and military combat. Despite there being a number of treatments for PTSD, there is a need to help people who have treatment-resistant PTSD and do not benefit from these treatments as many individuals continue to experience marked PTSD symptoms following treatment. In response to overwhelming demand, several U.S. states have passed laws allowing the medical use of cannabis (marijuana) by individuals with PTSD. Unfortunately, there has been very little scientific evidence on suitability of cannabis as an alternative therapy for PTSD. The purpose of this study is to find out if cannabis can reduce PTSD symptoms in 76 military veterans with treatment-resistant PTSD. Four different types of smoked cannabis will be evaluated using a "triple-blind" cross-over placebo controlled design. Study participation will last 8.5 months. Participants will select a community observer, a friend or relative who can be contacted by the researchers, who will report on the participant's health and well-being throughout the study. After screening and meeting study requirements, participants will be randomly assigned to receive one of four types of cannabis that vary based on THC and CBD content. During the study, each participant will smoke two of the four types of cannabis, up to 1.8 grams per day, for a 3-week period. Participants can smoke their daily 1.8g cannabis at any time, using as much as they need. After each 3-week cannabis use period, they will stop smoking marijuana/cannabis for two weeks where no cannabis use will be allowed. Study findings will help researchers better understand the risks and benefits associated with cannabis use among veterans with PTSD, information that can be used to aid in shared decision-making among people with PTSD and their doctors or therapists.

Posttraumatic Stress Disorder (PTSD), characterized by an inability to recover from a stress reaction to a traumatic event, is a widely prevalent disorder within the U.S. and across the world. Currently, several psychotherapies are empirically-supported for the treatment of PTSD. However, because of treatment refusal due to treatment type, non-response, and dropout, many individuals continue to experience severe symptoms and meet criteria for PTSD following treatment.

Emerging observational and early clinical evidence suggest that cannabis (marijuana) may have the potential to reduce or ameliorate a number of symptoms experienced by those with PTSD, including sleep difficulty and anxiety. Indeed, some evidence has suggested that delta-9-tetrahydrocannabinol (THC) may serve to reduce nightmares among those with PTSD, while other studies have shown anxiolytic effects of cannabidiol (CBD). However, there have been no randomized controlled trials of cannabis, in any form, for PTSD.

The present triple-blind, randomized, placebo-controlled crossover trial aims to examine the safety and efficacy of four types of cannabis (i.e., high THC, low CBD; high CBD, low THC; equal ratio THC/CBD; and placebo) among 76 military veterans with treatment-resistant PTSD. Participants will be recruited from one study site, the Scottsdale Research Institute (Phoenix, AZ).

After giving written informed consent, participants will undergo screening for initial eligibility. Potential participants will be required to stop using non-study medical cannabis for two weeks during screening, and for the duration of the study if enrolled. After the two-week washout, a blinded independent rater will administer the Clinician-Administered PTSD Scale (CAPS-5) to assess presence and severity of PTSD symptoms. Self-report measures will also be completed. Eligible participants will then be enrolled and randomized. In the active portion of the study, participants will receive two of four different types of cannabis during two stages (Stage 1 and Stage 2), each lasting three weeks, with crossover and re-randomization at Stage 2. Prior to each stage, participants will complete two introductory sessions where they will be trained on cannabis self-administration. During each stage, participants will be provided 1.8 grams of cannabis daily to smoke ad libitum. Each stage will be followed by a two-week cessation. To reduce the risk of diversion, after the second cessation period, participants will have the option to complete a third stage of the study where they can request the remaining unused cannabis from either Stage 1 or 2. All participants will complete a six-month follow-up after completion of the experimental portion of the study.

Study outcomes will be assessed objectively, behaviorally, via self-report, and by a third-party rater. Specifically, blood and urine will be collected to confirm cannabis use status throughout the study, participants will be required to video record self-administration of cannabis, and any unused cannabis from each weekly allotment will be returned to the investigator or designee to be weighed and accounted for prior to dispensing of the next weekly supply. Sleep will be measured via self-report and tracked with actigraphy, clinical interviews will be conducted by blinded independent raters, and a participant-identified community observer will provide an independent rating of participant behavior.

Participant suicidal ideation will be assessed weekly with the C-SSRS, and daily if results indicate development of suicidal ideation. Weekly evaluations will include measures of symptoms of PTSD, depression, anxiety, sleep quality, general functioning, and responses to cannabis. During each evaluation, actigraph data will also be downloaded and a urine-dip EtG test will be performed. Analysis of blood/urine cannabinoids will be conducted after cessation periods, in addition to weekly urine drug screening for substances other than cannabis. At Baseline and end of Stage 1, Cessation 1 and end of Stage 2, additional blood samples will be collected for analysis of inflammation markers. At the end of Stage 1 and 2, endpoint measures will be administered; an independent rater will evaluate symptoms of PTSD on the CAPS-5 via telemedicine, and self-reported symptoms of anxiety, depression, withdrawal, sleep quality, and psychosocial functioning will be assessed.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
  • Drug: High THC Marijuana
    Three weeks of smoking marijuana containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
    Other Names:
    • Tetrahydrocannabinol
    • cannabis
  • Drug: High CBD Marijuana
    Three weeks of smoking marijuana containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
    Other Names:
    • cannabidiol
    • cannabis
  • Drug: High THC/high CBD marijuana
    Three weeks of smoking marijuana containing equal amounts of THC and CBD, with smoking limited to no more than 1.8 g per day.
    Other Names:
    • tetrahydrocannabinol
    • cannabidiol
    • cannabis
  • Drug: Placebo marijuana
    Three weeks of smoking marijuana with low levels of THC and CBD, with smoking limited to no more than 1.8 per day.
    Other Name: cannabis
  • Experimental: High THC marijuana
    Provided with up to 1.8 g of marijuana with more tetrahydrocannabinol than cannabidiol
    Intervention: Drug: High THC Marijuana
  • Experimental: High CBD marijuana
    Provided with up to 1.8 g of marijuana per day of marijuana with more cannabidiol than tetrahydrocannabinol
    Intervention: Drug: High CBD Marijuana
  • Experimental: High THC/high CBD marijuana
    Provided with up to 1.8 g per day of marijuana with an approximately equal amount of tetrahydrocannabinol and cannabidiol
    Intervention: Drug: High THC/high CBD marijuana
  • Placebo Comparator: Placebo marijuana
    Provided with 1.8 per day of marijuana with very low levels of tetrahydrocannabinol and cannabidiol
    Intervention: Drug: Placebo marijuana
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
January 2019
August 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have chronic treatment resistant PTSD of at least six months duration.
  • Have PTSD of at least moderate severity at the time of baseline assessment.
  • Be a military veteran with service-related PTSD.
  • Be at least 18 years old.
  • Be willing to commit to medication dosing and delivery method, to completing evaluation instruments, and attending all study visits.
  • Agree to use only marijuana provided by site staff and agree to required cessation periods for the duration of the study.
  • Report no current hazardous marijuana use and completely abstain from marijuana during the 2-week baseline assessment period (verified via urine and/or blood cannabinoid concentrations).
  • Agree to video record all marijuana administrations and provide video to the site staff for review during study participation.
  • Agree to keep all marijuana provided by site staff securely stored in the provided lock box and not to share/distribute marijuana to any other individual.
  • Agree to provide a self-appointed community observer who they interact with regularly and who can be contacted by the site staff for interviews and to verify compliance with the study protocol.
  • Be stable on any pre-study medications and/or psychotherapy regimen for PTSD prior to study entry, agree to notify their physician/clinician about participation in the study, and agree to report any changes in medication or psychotherapy treatment regimen during the study, to site staff.
  • If female and of childbearing potential, agree to use an effective form of birth control during study participation and may only be allowed to enroll and continue in the study based on a negative pregnancy test.
  • Be proficient in reading and writing in English and able to effectively communicate with site staff.
  • Agree not to participate in any other interventional clinical trials during the study

Exclusion Criteria:

  • Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study.
  • Have any allergies to marijuana or contraindication for smoking of marijuana.
  • Are abusing illegal drugs;
  • Are not able to give adequate informed consent.
  • Are not able to attend face-to-face visits or those who plan to move out of the area within the treatment period.
  • Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Benjamin Shechet ben@sriresearch.org
United States
 
 
NCT02759185
MJP-1
No
Not Provided
Plan to Share IPD: Undecided
Multidisciplinary Association for Psychedelic Studies
Multidisciplinary Association for Psychedelic Studies
Not Provided
Study Director: Marcel Bonn-Miller, PhD University of Pennsylvania
Multidisciplinary Association for Psychedelic Studies
September 2017

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