The Efficacy of Cannabis Products for Treating PTSD among Combat Veterans

Informed Consent and Debriefing

The purpose of this paper is to create an informed consent form and a debriefing form that explain the nature and true purpose of a proposed clinical study concerning the use of legal, edible cannabis products to treat post-traumatic stress disorder (PTSD) among American male combat veterans of all ages and branches of military service. Cannabis products are currently legal in more than half of U.S. states and the recreational use of these products has been legalized by numerous others. There is also movement in the U.S. Congress to legalize cannabis products at the federal level, opening the way for veterans to receive them as part of their health care regimen (Hill, Loughlin, Nichter et al., 2021).

Although younger veterans tend to report significantly higher usage rates of cannabis products compared to their older counterparts, the research to date confirms that overall usage of cannabis among veterans has increased in recent years (Hill et al., 2021). In addition, the use of cannabis products among combat veterans of all ages is also higher compared to noncombat veterans (Hill et al., 2021). These are important issues since more than a half million veterans in the post-Vietnam era have been diagnosed with PTSD, and the numbers may be far higher due to a lack of identified cases (PRNewswire, 2021).

At present, though, because cannabis remains a scheduled narcotic under federal law, there has been a dearth of timely and relevant research concerning its medicinal effects in general and for the treatment of the symptoms of post-traumatic stress disorder (PTSD) in particular. The scant amount of research that has been conducted, however, suggests that male veterans of all ages benefit more from cannabis use and there are a number of ongoing clinical trials being conducted to explore these issues further. In addition, anecdotal evidence and empirical observations indicate that cannabis products can alleviate symptoms and provide relief for veterans suffering from PTSD (PRNewswire, 2021). The informed consent form and debriefing form which follow below are intended for use in a proposed clinical study concerning the efficacy of using edible cannabis products selected and purchased by combat veterans with valid medical marijuana licenses in their respective states.

Medical Marijuana Consent Form

First and foremost, it is important to note that qualified physicians are not authorized to assign the responsibility of obtaining written informed consent to another person and all qualified patients must initial each section of this consent form to indicate that their physician thoroughly and clearly explained the information and, together with the qualified physician, must sign and date the informed consent form set forth below. Study participants will be followed by their primary VA physician during the conduct of this study over the course of one year (12 monthly appointments) and the results of these visits will be analyzed to evaluate the effectiveness of edible cannabis products for treating PTSD symptoms. This consent form contains two parts. Part A must be completed by all patients. Part B is the signature block and must be completed by all patients or their authorized caregiver.

Part A: Must be completed by all veterans

a. The federal government's classification of marijuana as a Schedule I controlled substance.

___ At present, the federal government classifies marijuana as a Schedule I controlled substance defined, in part, as having (1) a high potential for abuse; (2) no currently accepted medical use in treatment in the U.S.; and (3) a lack of accepted safety for use under medical supervision. In addition, federal law also currently prohibits the manufacture, distribution and possession of marijuana even in states which have modified their state laws to treat marijuana as a medicine.

_____ Patients or patient's caregiver must have his medical marijuana use registry identification card in his or her possession at all times when in the possession of medical marijuana.

b. The potential effects of marijuana on patients’ coordination, motor skills, and cognition, including warnings against operating heavy machinery, operating motor vehicles, or engaging in activities that require alertness or the ability to respond quickly.

_____ The use of marijuana has been shown to affect coordination, motor skills and people’s ability to think, judge and reason. Therefore, I should not drive, operate heavy machinery or engage in any activities that require me to be alert and/or respond quickly and I should not participate in activities that may be dangerous to myself or others when using medical marijuana.

c. The potential side effects of medical marijuana use.

_____ Potential side effects from the use of marijuana include, but are not limited to, the following: anxiety, confusion, dizziness, sedation, low blood pressure, short- term memory impairment, euphoria, and difficulty in completing complex tasks. In addition, other side effects may include suppression of the body's immune system, the production of sex hormones that can cause adverse effects, an inability to concentrate, impaired motor skills, paranoia, psychotic symptoms, general apathy, depression and/or restlessness. Further, marijuana may exacerbate schizophrenia in people who are predisposed to the condition. Finally, medical marijuana may cause me to talk or eat excessively, alter my perception of time and space and impair my judgment.

_____ I understand that using alcohol while using medical marijuana is not recommended and additional side effects may occur when using both alcohol and marijuana (Medical marijuana consent form, 2020).

d. The current state of research on the efficacy of marijuana to treat PTSD.

The limited amount of research to date indicates that cannabis products may be effective in treating the symptoms of PTSD, and that male veterans of all ages tend to experience superior clinical outcomes compared to female veterans of all ages.

Part B. Physician and patient signatures

Dr. Jeffrey G. Smith (or applicable name) has informed me of the risks, complications, and expected benefits of any recommended treatment, including its likelihood of success and failure. I acknowledge that Dr. Smith informed me of any alternatives to the recommended treatment, including the alternative of no treatment, and the risks and benefits. Finally, Dr. Smith has also explained the information in this consent form about the medical use of marijuana.

Patient (print name) __________________________________________________

Patient signature or signature of the patient’s authorized caregiver:

Date ___________

I have explained the information in this consent form about the medical use of marijuana to