Warrior CARE: Cannabis Behavioral Health

Official title

Wayne Warrior CAnnabis Research and Education: Cannabis and Behavioral Health

Overview

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

Detailed description

In this clinical trial, we will recruit veterans with PTSD who report using cannabis or have interest in trying cannabis for symptom relief. Veterans will be randomized into one of four different groups: THC (∆9-tetrahydrocannabinol), CBD (cannabidiol), THC+CBD, and Placebo, and undergo a 12-week treatment phase where they will be asked to smoke their assigned cannabis dose every day for 12 weeks. Participants will complete weekly questionnaires regarding their mood, behavior and drug consumption. Furthermore, there is a laboratory component that will assess cognition, fear conditioning, and other PTSD-related measures.

Interventions

• Drug Tetrahydrocannabinol
  Plant cannabis that will be smoked
• Drug Cannabidiol
  Plant cannabidiol that will be smoked
• Drug Placebo
  Plant will be smoked.

Primary outcome measures

• Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment. [Time frame: Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).]
• Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment [Time frame: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months]
• Assessing Suicidality over time using the C-SSRS assessment. [Time frame: Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).]
• Assessing Suicidality throughout the study using the SBQ-R assessment. [Time frame: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months]
• Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires. [Time frame: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months]

Secondary outcome measures (12)

• Assess emotional state pre- and post-treatment using the PANAS questionnaire. [Time frame: Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).]
• Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment. [Time frame: Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).]
• Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments. [Time frame: Administered at a pre-treatment visit (at the baseline visit); and at the four post-treatment visits (one week post-treatment, and 3-, 6-, and 9-months post-treatment).]
• Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales. [Time frame: Administered after cannabis administration; therefore, administered at the baseline visit and electronically during the 12-week treatment phase (at all twelve weekly visits).]
• Assess demographics using a self-report assessment [Time frame: Administered once at a pre-treatment visit, specifically at the initial screening visit.]
• Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments. [Time frame: Administered once at a pre-treatment visit, specifically at the baseline visit.]
• Assess smoking habits and history using the FTND assessment [Time frame: Administered once at a pre-treatment visit, specifically at the baseline visit.]
• Assess general health and history pre- and post-treatment using the SF-36 assessment. [Time frame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).]
• Assess healthcare utilization throughout the study. [Time frame: Administered at both pre-treatment visits (the initial screening and baseline visit); and at two post-treatment visits (one week post-treatment and 3-months post-treatment visits).]
• Assess pain pre- and post-treatment using the BPI assessment. [Time frame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).]
• Assess sleepiness pre- and post-treatment using the ESS questionnaire. [Time frame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).]
• Assess overall quality of life pre- and post-treatment using the QOL questionnaire. [Time frame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).]

Eligibility criteria

Inclusion criteria

• a healthy veteran who has served in a branch of the US armed forces
• report using cannabis within the past year
• currently meet DSM-5 criteria for PTSD and a score of 25 or greater on the CAPS-5 (the anchor, or index, trauma does not have to be related to military service)
• between the ages of 19-69 years old
• not seeking treatment for Cannabis Use Disorder
• stable (i.e., under the care of a physician or therapist and not experiencing acute symptoms) on psychotropic medications and/or psychotherapy before the study begins (participants can be in treatment for PTSD)
• agree to adhere to study procedures

Exclusion criteria

• pregnant, lactating, or heterosexually active women and not using medically approved birth control
• current or past bipolar or psychotic disorder as determined using the SCID-5
• at immediate high risk for suicide based on the C-SSRS
• current SUD other than Nicotine Use Disorder and Alcohol Use Disorder (mild or moderate)
• allergies and/or other contradictions for using cannabis
• any clinically significant medical problems
• systolic/diastolic BP >140/90 mmHg or systolic BP <95 mmHg
• elevated liver function tests
• exhibit cognitive impairment (<80 IQ)
• enrolled in another clinical trial or have received any drug as part of a research study within 30 days of dosing
• used a prescription medication (with the exception of birth control) within 14 days of study entry that in the opinion of the medically responsible investigator will interfere with the safety of the participant or the study results
• unable to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Wayne State University — Detroit

Publications

• Tashkin DP, Roth MD. Pulmonary effects of inhaled cannabis smoke. Am J Drug Alcohol Abuse. 2019;45(6):596-609. doi: 10.1080/00952990.2019.1627366. Epub 2019 Jul 12. PMID 31298945
• Huang YH, Zhang ZF, Tashkin DP, Feng B, Straif K, Hashibe M. An epidemiologic review of marijuana and cancer: an update. Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):15-31. doi: 10.1158/1055-9965.EPI-14-1026. PMID 25587109
• Taylor DR, Fergusson DM, Milne BJ, Horwood LJ, Moffitt TE, Sears MR, Poulton R. A longitudinal study of the effects of tobacco and cannabis exposure on lung function in young adults. Addiction. 2002 Aug;97(8):1055-61. doi: 10.1046/j.1360-0443.2002.00169.x. PMID 12144608
• Tashkin DP, Simmons MS, Sherrill DL, Coulson AH. Heavy habitual marijuana smoking does not cause an accelerated decline in FEV1 with age. Am J Respir Crit Care Med. 1997 Jan;155(1):141-8. doi: 10.1164/ajrccm.155.1.9001303. PMID 9001303
• Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035. PMID 17606655
• Baldwin GC, Tashkin DP, Buckley DM, Park AN, Dubinett SM, Roth MD. Marijuana and cocaine impair alveolar macrophage function and cytokine production. Am J Respir Crit Care Med. 1997 Nov;156(5):1606-13. doi: 10.1164/ajrccm.156.5.9704146. PMID 9372683
• Tetrault JM, Crothers K, Moore BA, Mehra R, Concato J, Fiellin DA. Effects of marijuana smoking on pulmonary function and respiratory complications: a systematic review. Arch Intern Med. 2007 Feb 12;167(3):221-8. doi: 10.1001/archinte.167.3.221. PMID 17296876
• Tashkin DP, Fligiel S, Wu TC, Gong H Jr, Barbers RG, Coulson AH, Simmons MS, Beals TF. Effects of habitual use of marijuana and/or cocaine on the lung. NIDA Res Monogr. 1990;99:63-87. No abstract available. PMID 2267014

Identifiers

NCT: NCT06381180 · Warrior CARE: CBH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗