Opioids and Smoking Cessation

NCT03857139 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-05-20

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857139 on ClinicalTrials.gov