Medicinal Nicotine for Harm Reduction? Developing Effects and Assessing Policy

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Project Summary:

Policies on using alternative nicotine delivery systems (for example, the patch, gum) for harm reduction in cigarette smokers are currently controversial. Some experts think it is ill-advised to recommend these products for long-term use, while others view these products as a way to deal with the large risks of cigarette use in smokers addicted to nicotine. If we know that a product (for example, medicinal nicotine) reduces risks to individuals, it may be unethical (that is, it may violate a human right for health relevant information) not to present long-term medicinal nicotine use as a possible option for smokers because of unclear concerns of a possible net loss for public health if many people came to use medicinal nicotine regularly. The risks from over-the-counter (OTC) medicinal nicotine appear to be so low that it is impossible for use to increase to an extent that would produce a net public health loss. There is an urgent need to have data that can guide policy. We need to determine how smokers respond to being offered the option to use medicinal nicotine on an ongoing basis if they won’t otherwise stop smoking. Is the message too complex to deliver? What do smokers understand? What do they remember from a clinical effort to persuade them to stop smoking that involves a harm reduction message? Does the information increase intentions to quit smoking? Do smokers themselves think they have a right to such information? Objective 1—Message Development—of this project is to develop and pretest a practical, brief, harm reduction message that can be used in the clinical setting to explain key options, including medicinal nicotine for harm reduction, that smokers have for dealing with the risks of cigarette smoking. Objective 2—Experimental Test of Harm Reduction Messages—is an experimental study on the effects of providing tobacco users with the option of medicinal nicotine for harm reduction. Smokers will receive either a “usual care,” strict abstinence package or a message package including advice on OTC medicinal nicotine for harm reduction. The outcomes of this study will be reactions of smokers to this information immediately and after six months, including intentions to quit smoking and use of OTC nicotine for harm reduction. This study will increase understanding of policy-relevant interventions to reduce harm caused by tobacco. Added value arises because this study will be conducted in a rural health clinic in Appalachia (70% Pennsylvania, 30% West Virginia). This is an underserved, high-risk group containing a relatively high percentage of cigarette smokers. Objective 3—Policy Evaluation—consists of an assessment of basic issues for key policy-makers and opinion leaders related to long-term use of nicotine replacement, in light of the results of our experimental study and in light of a policy evaluation essay that includes consideration of human rights themes. There will be two additional sources of data: 1. Interviews with six active clinicians representing different kinds of clinical practice, to assess reactions and opinion on generalizability of the results in our rural, low socioeconomic status practice 2. Development of a collaborative essay with 15 policy experts representing various domains of expertise (for example, law, ethics, medicine, psychology, economics, federal regulatory system)