Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
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|ClinicalTrials.gov Identifier: NCT04063267|
Recruitment Status : Not yet recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
NYU Langone Health
Information provided by (Responsible Party):
NYU Langone Health
Patients in addiction treatment have exceptionally higher rate of cigarette smoking and very low quit rates compared to the general population. The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes among patients in addiction treatment.
|Condition or disease||Intervention/treatment||Phase|
|Cigarette Smoking Addiction E Cig Use||Device: E cigarettes Other: Nicotine Replacement Therapy||Phase 2|
Electronic nicotine delivery devices often referred to as e-cigarettes, are battery-powered devices that deliver vaporized nicotine when inhaled. Corresponding with the growth in media attention, marketing and promotion, awareness and use of e-cigarettes has increased dramatically. A large proportion of those using e-cigarettes use them to reduce the number of cigarettes they are smoking or to help them quit. Use of an e-cigarette by smokers unwilling or unable to stop smoking completely might be a good approach to reducing cigarette consumption as the e-cigarette imitates some behavioral aspects of cigarette smoking and contains nicotine. Moreover, the few existing studies on the effect of e-cigarettes on tobacco withdrawal and craving suggest promising potential to assist smokers in coping with smoking urges and decreasing cigarette use.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder|
|Estimated Study Start Date :||September 15, 2019|
|Estimated Primary Completion Date :||September 15, 2020|
|Estimated Study Completion Date :||September 15, 2020|
|Experimental: E cigarettes||
Device: E cigarettes
Participants will be encouraged to substitute e-cigarettes for combustible cigarettes in order to reduce nicotine withdrawal symptoms
|Active Comparator: Nicotine Replacement Therapy||
Other: Nicotine Replacement Therapy
Nicotine patches and gum to last them the first week based on their baseline recorded smoking. Participants will be advised to use both a 21 mg nicotine patch and 4 mg nicotine for cravings.
Primary Outcome Measures :
- Proportion of participants who achieve 50% reduction in CPD at 3 weeks. [ Time Frame: 3 Weeks ]proportion of participants who achieve 50% reduction in CPD at 3 weeks.
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