The title of the present study is “Smoked Marijuana for HIV-Associated Anorexia and Wasting”. It is a randomized, double-blind, placebo-controlled evaluation of the effect of smoking marijuana on the appetite of HIV patients, conducted in an inpatient setting. The primary objective of the study is “To evaluate the safety and efficacy of moderate (~4%) THC-content smoked marijuana as an appetite stimulant in persons with HIV disease”1.
The treatment is separated into five distinct stages2. First, there will be a 5-day lead-in phase to obtain the necessary measurements and perform preliminary tests. Following this period, the subjects will either receive moderate (~.4%) THC- content marijuana cigarettes or placebo marijuana cigarettes for the period of five days, followed by a four-week homestay period needed to decrease the concentration of marijuana in the body to reduce the possibility of adverse effects. During the second five-day inpatient treatment, the patient groups are crossed over, which means that the group that received placebo cigarettes will now receive (~.4%) THC- content marijuana cigarettes and vice versa.
According to the Protocol, the subject population will consist of HIV and AIDS patients with moderate to significant weight loss who have previously used marijuana3. As Abrams notes, subjects will be recruited from the community providers who are participating in the Community Consortium’s community-based clinical trials program4. Initial inclusion criteria include a supported diagnosis of HIV or AIDS and the weight loss of 5-15% of the ideal body weight5. Further tests to assess the subjects’ appetite, food intake, body composition, energy expenditure, THC, and testosterone levels, as well as other studies will be performed to evaluate the subject’s eligibility to take part in the study6. The planned accrual of this study is 15 patients7. The experiment will consist of 20 inpatient days plus 28 break, or 48 days in total.
As the authors of the study note, using marijuana for the treatment of any disease or condition is highly controversial. Marijuana is a drug that is banned in half of the U. S. states due to its threat to people’s health and wellbeing. Abrams states that in patients who do not have HIV, marijuana may have an adverse effect on the immune system, be harmful to the lungs, and affect the endocrine system, causing the patients to require testosterone replacement therapy. However, Abrams also notes that there are also studies that show that marijuana can cause temporary cognitive impairment8. The treatment of anorexia and wasting in HIV patients has never been properly studied to determine if it is worth the safety risks9. Therefore, the fact that the study uses fifteen subjects for an initial trial to determine both the positive influence and the possibility of adverse effects of marijuana use in the chosen population creates concern for the safety of the subjects.
There are three major ethical concerns with the protocol. First, as noted by the researchers, in case there is any injury or condition resulting from this study, the cost of treatment will not be covered by the Community Consortium. While this is a normal procedure for the studies of the Community Consortium, in this case, this condition is not entirely ethical. Due to the possible increased risk of pulmonary disease associated with the use of marijuana and the overall uncertainty regarding its health outcomes, the researchers and sponsors should take it upon themselves to cover the medical expenses arising out of the subject’s participation in the study. Second, the use of placebo control in clinical trials is highly controversial as it involves deceiving the participants into thinking that they are taking active medication and exposing the subjects to the potential damage from non-treatment. Abrams discusses Foltin’s 1986 experiment where the researcher compared the effect of marijuana smoking on appetite with the use of placebo controls10, which is why it is unnecessary to use placebo controls in the present study. Lastly, it is unclear whether or not the researchers were planning to inform the subjects about all the possible health outcomes of this study. Obtaining the subjects’ informed consent is addressed; however, Abrams does not describe the contents of the information that will be revealed to the participants, including the information regarding the potential damage to their health and wellbeing.
Overall, the researchers would benefit from disclosing additional information to the subjects. For example, it is necessary to disclose information regarding the aim of the study and the purpose for which the study is conducted. Moreover, the subjects should be aware of all the details of their treatment in order to make an informed decision on whether or not they want to proceed. Furthermore, they should receive information regarding the possibility of exiting the study if they find themselves to be uncomfortable or to experience any side effects. Most importantly, however, it is crucial to disclose all the information on the possible side effects and adverse effects associated with the use of marijuana. The subjects must be fully informed that no research has been conducted on the HIV patients’ reaction to marijuana and that they may experience health problems as a result of the experiment. Disclosing all the necessary information to the subjects would help to protect their rights in case of any unwanted effects, thus making the experiment ethically valid.
Bibliography
Abrams, Donald I. “Protocol: Smoked Marijuana for HIV-Associated Anorexia and Wasting,” Research Plan Portion of Public Health Service Grant Application, 1996.
Footnotes
- Donald I. Abrams, “Protocol: Smoked Marijuana for HIV-Associated Anorexia and Wasting,” Research Plan Portion of Public Health Service Grant Application, 1996, 2.
- Ibid., 1.
- Ibid., 17.
- Ibid.
- Ibid.
- Ibid.
- Ibid., 1.
- Ibid., 6.
- Ibid., 2.
- Ibid., 7-8.