Design and methods of the Population Assessment of Tobacco and Health (PATH) Study.

BACKGROUND: This paper describes the methods and conceptual framework for Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study data collection. The National Institutes of Health, through the National Institute on Drug Abuse, is partnering with the Food and Drug Administration's (FDA) Center for Tobacco Products to conduct the PATH Study under a contract with Westat. METHODS: The PATH Study is a nationally representative, longitudinal cohort study of 45 971 adults and youth in the USA, aged 12 years and older. Wave 1 was conducted from 12 September 2013 to 15 December 2014 using Audio Computer-Assisted Self-Interviewing to collect information on tobacco-use patterns, risk perceptions and attitudes towards current and newly emerging tobacco products, tobacco initiation, cessation, relapse behaviours and health outcomes. The PATH Study's design allows for the longitudinal assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse and transitions between products, as well as factors associated with use patterns. Additionally, the PATH Study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use. CONCLUSIONS: The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform FDA's regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation's burden of tobacco-related death and disease.

Alcohol risk-reduction skills training in a national fraternity: a randomized intervention trial with longitudinal intent-to-treat analysis.

OBJECTIVE: The potential effectiveness of two group-administered social-skills training interventions for reducing high-risk drinking behavior was evaluated through a prospective randomized intervention trial with 3,406 members of a national college fraternity. METHOD: Ninety eight of 99 chapters of a national fraternity were randomly assigned, within three strata, to receive (1) a 3-hour baseline intervention, (2) the same baseline intervention plus two booster sessions, or (3) assessments only. The current article emphasizes a rigorous intent-to-treat analysis model that compares outcomes among members assigned to receive study interventions (vs assessment-only sites) regardless of whether they actually did receive them; it also includes individuals at intervention sites even if they did not participate. This model allows us to address a social policy issue regarding the effect that introducing such an intervention may have in changing the high-risk normative drinking environment of the fraternity itself. RESULTS: Frequent heavy drinkers (64.2% of members) assigned to either intervention showed significant reductions at a 6-month follow-up in their frequency of drinking, heavy drinking, and drinking to intoxication; plus, they reported consuming fewer drinks overall. At 12 and 18 months postbaseline, these positive outcomes had largely dissipated. Additionally, there was an increase in drinking among lower-risk members 18 months postbaseline, which may be the result of factors other than differential attrition. CONCLUSIONS: Findings suggest that introducing such a brief intervention can effectively reduce risky drinking behavior on a short-term basis in high-risk members of a national fraternity. Future studies may wish to focus on strategies for sustaining positive outcomes for longer, plus would benefit, in general, from learning more about mechanisms of change.

High-risk drinking among college fraternity members: a national perspective.

This survey, with its 85% response rate, provides an extensive profile of drinking behaviors and predictors of drinking among 3,406 members of one national college fraternity, distributed across 98 chapters in 32 states. Multiple indexes of alcohol consumption measured frequency, quantity, estimated blood alcohol concentration levels (BACs), and related problems. Among all members, 97% were drinkers, 86% binge drinkers, and 64% frequent binge drinkers. On the basis of self-reports concerning the 4 weeks preceding the time of survey, the authors found that members drank on an average of 10.5 days and consumed an average of 81 drinks. Drinkers had an average BAC of 0.10, reaching at least 0.08 on an average of 6 days. These fraternity members appear to be heavier drinkers than previously studied fraternity samples, perhaps because they were more representative and forthright. All 6 preselected demographic attributes of members and 2 chapter characteristics were significantly related to the drinking behaviors and levels of risk, identifying possible targets for preventive interventions.

Examining the effects of a national alcohol-free fraternity housing policy.

This investigation examined the effectiveness of an alcohol-free fraternity housing policy on the risky alcohol use of members of a national fraternity (N=718). Comparisons of members in chapters with fraternity housing (FH) and those in chapters without housing (NFH) over time revealed no policy-related effects on measures of alcohol use. Among FH members, comparisons of those who lived in fraternity housing and those who lived in other housing also found no effects. FH members reported that the policy was implemented moderately well; however, it may have shifted alcohol use from fraternity housing to other settings.

Barriers to the use of medications to treat alcoholism.

In 1994, naltrexone became the first medication approved by the Food and Drug Administration as an adjunct in alcoholism treatment in almost fifty years. Despite evidence of its efficacy, use of naltrexone is not widespread. Patient and physician focus groups were used to identify reasons naltrexone has not been prescribed more widely. Barriers to its widespread use include a lack of awareness, a lack of evidence of efficacy in practice, side effects, time for patient management, a reluctance to take medications, medication addiction concerns, Alcoholics Anonymous (AA) philosophy, and price. The study indicates that medications to treat alcoholism must overcome numerous barriers before becoming widely accepted.

Physicians' opinions about medications to treat alcoholism.

AIMS: Medications play a limited role in the treatment of alcoholism. This paper examines physicians' opinions about and use of two alcoholism medications currently approved in the US--disulfiram and naltrexone--and one alcoholism medication--acamprosate--that might be approved. DESIGN: A total of 1388 substance abuse specialist physicians who were members of the American Academy of Addiction Psychiatry or the American Society of Addiction Medicine completed a questionnaire in 2001 (65% response rate). FINDINGS: The average percentages of physicians' patients with alcoholism who were prescribed the following medications were: 13% (naltrexone), 9% (disulfiram), 46% (antidepressants) and 11% (benzodiazepines). Almost all physicians had heard of naltrexone and disulfiram, but their self-reported level of knowledge about these medications was lower than for antidepressants. Physicians estimated that naltrexone had a small-to-medium effect size, which was similar in magnitude to the effect size reported in recent meta-analyses of randomized clinical trials. Physicians identified the following three courses of action as the most likely to result in greater use of medications to treat alcohol dependence: more research to develop new medications (33%), more education of physicians about existing medications (17%), and increased involvement of physicians in alcoholism treatment (17%). CONCLUSIONS: Physicians' low rate of use of naltrexone may reflect its small-to-medium effect size.