SOFT - TIAFT 1998 Poster Session 1 Wednesday October 7, 1998

Byron M. King, Fred Snyder, Richard Frank*, Kenzie Preston, Stephen Heishman, Eric Moolchan, Richard Nelson, David Gorelick and Marilyn Huestis

IRP, NIDA, NIH, 5500 Nathan Shock Drive, Baltimore, MD 21224, USA
* Sanofi Pharmaceuticals, Inc., 9 Great Valley Parkway, Malvern, Pennsylvania 19355

For the recruitment of human participants for an ongoing marijuana dosing protocol, the Intramural Research Program (IRP) of the National Institute on Drug Abuse (NIDA) has adapted multiple highly effective means of recruiting participants for research studies. Ethical guidelines require that for the protection of human participants, study candidates must have documented prior drug use and be of sufficient medical and psychological health to provide adequate informed consent. Participants for research studies have been recruited through word of mouth referral, advertisements in regional and local newspapers, daily cable television advertisements, and through the posting of informational flyers on local college campuses, in bars, coffee houses, and shops specializing in drug paraphernalia. These methods provide a wide pool of applicants, which is necessary due to the stringent medical and safety requirements of the study.

Out of 2991 telephone calls and walk-ins recruited for the marijuana study, 48% or 1425 candidates successfully completed the initial telephone drug and psychological history screening. These candidates were scheduled for further interviews. Thirty-nine percent or 559 participants received complete physical exams and extensive clinical laboratory and psychological evaluations. Seventeen percent or 99 participants were admitted to the pre-treatment phase of the study. Following further medical and psychological evaluations, 48% or 48 participants were randomized for experimental dosing. Most of the candidates initially screened were disqualified from participating in the study due to many factors, including: current active disease, clinical laboratory abnormalities, allergies, psychological or behavioral competence, current drug dependence or treatment, or an inability to comply with all study requirements due to legal or family social issues.

These factors represent a significant challenge to the recruitment of human research participants for drugs of abuse studies. The NIDA IRP has, over many years, developed procedures and personnel to address these issues to successfully recruit research participants, taking care to maintain the highest safeguards for the protection of human volunteers.

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