Opioids and Smoking Cessation

NCT03857139 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY00001467
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Point Prevalence Abstinence

  CO Biochemical Verification of smoking abstinence

  3 months post-quit date

Study Arms (1)

NRT smoking Cessation Intervention

EXPERIMENTAL

All participants will be provided with the Nicotine Patch as an intervention

Drug: Nicotine patch

Interventions

Nicotine patch DRUG

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.

Also known as: Nicotine Replacement Therapy, Transdermal Nicotine Patch

NRT smoking Cessation Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18-65 years of age. 2. Daily smoker (≥ 10 cigarettes per day for at least one year), biochemically confirmed via Carbon Monoxide \[CO\] analysis at least 8 ppm.
• \. Motivation to quit smoking (≥ 5 on a 0-10 scale) 4. Interested in making a serious quit attempt in the next month 5. Not have decreased number of cigarettes by more than half in the past 6 months 6. Own a smartphone (for EMA) 7. Report of current (past 30-day) opioid use (opioid misuse group) 8. Verification of opioid use by positive urine toxicology screen \& Positive Aberrant Drug Behavior Index (opioid misuse group)
• PDUQ \> 11, +POTQ, +urine toxicology screen

You may not qualify if:

• \. Current use of psychotropic medication. 2. Current use of nicotine replacement therapy, Zyban, or Chantix (or intention to use).
• \. Use of other tobacco products, including e-cigarettes. 4. Current treatment for opioid misuse, including methadone, buprenorphine, or naltrexone.
• \. Current diagnosis of Opioid Use Disorder. 6. Pregnancy (by self-report) 7. Limited mental capacity or inability to provide informed consent 8. Current suicidality (by structured clinical interview) 9. Lifetime or current psychosis

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

Anxiety and Health Research Laboratory

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Smoking; Opioid-Related Disorders

Interventions

Tobacco Use Cessation Devices; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Tobacco Use; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Drug Therapy

Study Officials

• Andrew H Rogers, M.A.

  University of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 27, 2019
• Study Start: December 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)