Study of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD
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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. |
ClinicalTrials.gov Identifier: NCT02759185 |
Recruitment Status :
Completed
First Posted : May 3, 2016
Last Update Posted : June 25, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, 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 Posttraumatic Stress Disorder (PTSD) |
Actual Study Start Date : | January 2, 2017 |
Actual Primary Completion Date : | January 2019 |
Actual Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
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Experimental: High THC marijuana
Provided with up to 1.8 g of marijuana with more tetrahydrocannabinol than cannabidiol
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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:
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Experimental: High CBD marijuana
Provided with up to 1.8 g of marijuana per day of marijuana with more cannabidiol than tetrahydrocannabinol
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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:
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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
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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:
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Placebo Comparator: Placebo marijuana
Provided with 1.8 per day of marijuana with very low levels of tetrahydrocannabinol and cannabidiol
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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 |
- 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, a measure of PTSD symptom severity

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have 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 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.
- 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;

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 ClinicalTrials.gov identifier (NCT number): NCT02759185
United States, Arizona | |
Scottsdale Research Institute | |
Phoenix, Arizona, United States, 85027 |
Responsible Party: | Multidisciplinary Association for Psychedelic Studies |
ClinicalTrials.gov Identifier: | NCT02759185 |
Other Study ID Numbers: |
MJP-1 |
First Posted: | May 3, 2016 Key Record Dates |
Last Update Posted: | June 25, 2020 |
Last Verified: | November 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
PTSD marijuana cannabis |
sleep THC CBD |
Marijuana Abuse Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Substance-Related Disorders Chemically-Induced Disorders Dronabinol Epidiolex Anticonvulsants Hallucinogens Physiological Effects of Drugs |
Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |