title: Stakeholders' Views on Barriers to Research on Controversial Controlled Substances.
abstract: Many diseases and disease symptoms still lack effective treatment. At the same time, certain controversial Schedule I drugs, such as heroin and cannabis, have been reputed to have considerable therapeutic potential for addressing significant medical problems. Yet, there is a paucity of U.S. clinical studies on the therapeutic uses of controlled drugs. For example, people living with HIV/AIDS experience a variety of disease- and medication-related symptoms. Their chronic pain is intense, frequent, and difficult to treat. Nevertheless, clinical trials of compassionate management for their chronic symptoms, which should be a research priority, are stymied. We employed qualitative methods to develop an understanding of the barriers to research on potential therapeutic uses of Schedule I drugs so that they might be addressed. We elicited the perspectives of key stakeholder groups that would be involved in such studies: people living with HIV/AIDS, clinicians, and members of institutional review boards. As we identified obstacles to research, we found that all of the stakeholder groups arrived at the same conclusion, that clinical research on the therapeutic potential of these drugs is ethically required.
authors.affiliation: Icahn School of Medicine at Mt. Sinai, One Gustave L. Levy Place, Box 1076, Annenberg 12-42, New York, New York 10029 USA. erhodes@jhsph.edu.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Rhodes
authors.affiliation: Albert Einstein College of Medicine, Montefiore Medical Center, 111 E 210th St., Bronx, New York 10467 USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Andreae
authors.affiliation: Los Angeles, California USA.
authors.forename: Tyler
authors.initials: T
authors.lastname: Bourgiose
authors.affiliation: Icahn School of Medicine at Mt. Sinai, One Gustave L. Levy Place, Box 1076, Annenberg 12-42, New York, New York 10029 USA.
authors.forename: Debbie
authors.initials: D
authors.lastname: Indyk
authors.affiliation: Icahn School of Medicine at Mt. Sinai, One Gustave L. Levy Place, Box 1076, Annenberg 12-42, New York, New York 10029 USA.
authors.forename: Rosamond
authors.initials: R
authors.lastname: Rhodes
authors.affiliation: Icahn School of Medicine at Mt. Sinai, One Gustave L. Levy Place, Box 1076, Annenberg 12-42, New York, New York 10029 USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Sacks
mesh_terms: D001291:Attitude of Health Personnel; D035843:Biomedical Research / Q000941:ethics*; D061891:Controlled Substances; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D057545:Social Stigma; D019966:Substance-Related Disorders / Q000150:complications / Q000517:prevention & control
chemical_list: D061891:Controlled Substances