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Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users

2014-08-27 03:19:19 | BioPortfolio

Summary

Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.

Description

100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT.

Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams; well-known side effects of varenicline and secondary results are a qualitative description of nausea and dreams.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Tobacco Dependence

Intervention

support and visits, varenicline, placebo

Location

Gentofte Hospital
Copenhagen
Hellerup
Denmark
2900

Status

Recruiting

Source

University Hospital, Gentofte, Copenhagen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:19-0400

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Medical and Biotech [MESH] Definitions

Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.

Visits made by patients to health service providers' offices for diagnosis, treatment, and follow-up.

The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.

Use of TOBACCO (Nicotiana tabacum L) and TOBACCO PRODUCTS.

Inhaling and exhaling the smoke of tobacco or something similar to tobacco.

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