Informed Consent and Debriefing for Cannabis PTSD Study

Background and Study Overview

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 healthcare regimen (Hill, Loflin, 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 half a 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, because cannabis remains a Schedule I controlled substance under federal law, there has been a dearth of timely and relevant research concerning its medicinal effects in general and for the treatment of PTSD symptoms in particular. The limited research that has been conducted, however, suggests that male veterans of all ages benefit more from cannabis use, and a number of ongoing clinical trials are exploring these issues further. Anecdotal evidence and empirical observations also indicate that cannabis products can alleviate symptoms and provide relief for veterans suffering from PTSD (PRNewswire, 2021). The informed consent form and debriefing form 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 – Part A

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. 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 United States; and (3) a lack of accepted safety for use under medical supervision. In addition, federal law currently prohibits the manufacture, distribution, and possession of marijuana even in states that have modified their state laws to treat marijuana as a medicine.

_____ Patients or the patient's caregiver must have his or her medical marijuana use registry identification card in their possession at all times when in 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 while 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 completing complex tasks. Additional side effects may include suppression of the immune system, 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. Furthermore, marijuana may exacerbate schizophrenia in people who are predisposed to the condition. Finally, medical marijuana may cause excessive talking or eating, alter perception of time and space, and impair 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.