Search

Accurate medical histories for all NHRVs screening to participate in clinical pharmacology trials are vital to ensure volunteers' safety, and integrity of study results. Evidence from previous studies illustrate the potential for NHRVs to misrepresent their histories, especially when monetary incentives are offered, and the need to objectively verify these self-reported histories whenever practical. This study demonstrates that among the sample participants, all of whom self-reported a negative history of drug and alcohol abuse and tobacco smoking, 16% failed urine testing for either alcohol and drugs of abuse (6%), or cotinine (11%). Male sex and increased number of screenings in the preceding 12 months were significantly associated with increased odds for urine screen failure whereas increased enrollments in the same time period and increased study stipend decreased the same odds. These results emphasize the importance of diligently screening NHRVs participating in phase I clinical trails.

Background: Contingency management interventions that provide tangible incentives based on objective indicators of drug abstinence have improved treatment outcomes of substance abusers, but have not been widely implemented in community drug abuse treatment settings., Objective: To compare outcomes achieved when a lower-cost prize-based contingency management treatment is added to usual care in community methadone hydrochloride maintenance treatment settings., Design: Random assignment to usual care with (n = 198) or without (n = 190) abstinence incentives during a 12-week trial., Setting: Six community-based methadone maintenance drug abuse treatment clinics in locations across the United States., Participants: Three hundred eighty-eight stimulant-abusing patients enrolled in methadone maintenance programs for at least 1 month and no more than 3 years., Intervention: Participants submitting stimulant- and alcohol-negative samples earned draws for a chance to win prizes; the number of draws earned increased with continuous abstinence time., Main Outcome Measures: Total number of stimulant- and alcohol-negative samples provided, percentage of stimulant- and alcohol-negative samples provided, longest duration of abstinence, retention, and counseling attendance., Results: Submission of stimulant- and alcohol-negative samples was twice as likely for incentive as for usual care group participants (odds ratio, 1.98; 95% confidence interval, 1.42-2.77). Achieving 4 or more, 8 or more, and 12 weeks of continuous abstinence was approximately 3, 9, and 11 times more likely, respectively, for incentive vs usual care participants. Groups did not differ on study retention or counseling attendance. The average cost of prizes was 120 dollars per participant., Conclusion: An abstinence incentive approach that paid 120 dollars in prizes per participant effectively increased stimulant abstinence in community-based methadone maintenance treatment clinics.

Blood and breath are the specimens of choice for determining alcohol levels. A random urine specimen may not reflect a blood level because of the influences due to the stage of absorption, the quantity of urine in the bladder, and the frequency of urination. A urine sample may accurately reflect a blood level only 30 minutes after the bladder is completely emptied. Individual states that permit urinalysis for alcohol must provide procedures for sample collection and statutory limit levels.