Opioids and Smoking Cessation
NCT03857139 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2022-05-20
Summary
The selection hypothesis of smoking prevalence posits that smokers who are not able to quit successfully are "burdened" by specific characteristics that make it more challenging to quit1. For example, those less successful in quitting smoking may be more nicotine dependent or more likely to suffer from substance use, psychiatric, or medical conditions. In line with this perspective, smoking prevalence has stabilized in the US, presumably because the remaining population has become increasingly representative of those "at-risk smokers" who are unable to quit2. Emerging evidence suggests that persons who suffer from opioid misuse, defined as opioid use without a prescription, at a dose or frequency higher than prescribed, or for a non-medical purpose (e.g., getting high),3 may constitute such a high-risk group. Opioid misuse affects greater than 16% adults who use opioids4 and up to 29% of those with chronic pain.5 The prevalence of tobacco smoking in this group may exceed twice that observed in the general population, and smokers misusing opioids are almost twice as likely to be dependent on nicotine6,7. Yet, the role of opioid misuse in periods of early abstinence and smoking cessation has yet to be explored. The main objective of the present proposal is to fill existing gaps in knowledge by examining the extent to which opioid misuse is associated with decreased success during early smoking abstinence and over the course of an attempt to quit smoking, and to identify mediators and moderators of opioid-smoking relations in this context. This contribution is clinically-significant from a public health standpoint because it will directly guide the development of novel psychosocial/behavioral smoking cessation interventions to help this high-risk population of smokers quit by targeting unique vulnerability processes that result in poor cessation outcomes.
Conditions
- Smoking
- Smoking Cessation
- Smoking, Tobacco
- Opioid Use
- Opioid Abuse
Interventions
- DRUG
-
Nicotine patch
Participants will receive the transdermal nicotine patch (TNP) to use during the first 2 weeks post-quit. We chose the TNP because of the extensive empirical literature supporting its effectiveness and safety, ease of use, and relatively benign side effect profile. Anxiety and depressive symptoms predict poor smoking cessation outcomes among individuals receiving NRT , suggesting that emotional disturbance influences relapse even in the context of NRT.
Sponsors & Collaborators
-
University of Houston
lead OTHER
Principal Investigators
-
Andrew H Rogers, M.A. · University of Houston
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-31
- Primary Completion
- 2022-01-31
- Completion
- 2023-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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