Verified July 2016 by Multidisciplinary Association for Psychedelic Studies
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT02759185
First received: April 29, 2016
Last updated: July 21, 2016
Last verified: July 2016
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 | Drug: High THC Marijuana Drug: High CBD Marijuana Drug: High THC/high CBD marijuana Drug: Placebo marijuana |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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) |
- Change in CAPS Global Severity Score from baseline to primary endpoint [ Time Frame: Baseline, 3 weeks after randomization ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Clinician-Administered PTSD Scale, measure of PTSD symptoms
| Estimated Enrollment: | 76 |
| Study Start Date: | August 2016 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | August 2018 (Final data collection date for primary outcome measure) |
| Experimental: High THC marijuana
Provided with up to 1.8 g of marijuana with more tetrahydrocannabinol than cannabidiol |
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:
|
| Experimental: High CBD marijuana
Provided with up to 1.8 g of marijuana per day of marijuana with more cannabidiol than tetrahydrocannabinol |
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:
|
| 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 |
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:
|
| Placebo Comparator: Placebo marijuana
Provided with 1.8 per day of marijuana with very low levels of tetrahydrocannabinol and cannabidiol |
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 |
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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;
Please refer to this study by its ClinicalTrials.gov identifier: NCT02759185
| Scottsdale Research Institute | |
| Phoenix, Arizona, United States, 85027 | |
| Principal Investigator: Suzanne Sisley, MD | |
| Johns Hopkins University School of Medicine | |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: Ryan Vandrey, PhD | |
Multidisciplinary Association for Psychedelic Studies
| Study Director: | Marcel Bonn-Miller, PhD | University of Pennsylvania |
| Responsible Party: | Multidisciplinary Association for Psychedelic Studies |
| ClinicalTrials.gov Identifier: | NCT02759185 History of Changes |
| Other Study ID Numbers: | MJP-1 |
| Study First Received: | April 29, 2016 |
| Last Updated: | July 21, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Multidisciplinary Association for Psychedelic Studies:
| PTSD marijuana cannabis |
sleep THC CBD |
Additional relevant MeSH terms:
| Marijuana Abuse Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Substance-Related Disorders Chemically-Induced Disorders Dronabinol Hallucinogens |
Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on September 13, 2016