Low Nicotine Cigarettes, Smoking, and Chronic Pain (VLNCPain)

  • STATUS
    Recruiting
  • End date
    Jul 10, 2023
  • participants needed
    60
  • sponsor
    Duke University
Updated on 10 August 2022
cancer
chronic pain
back pain
Accepts healthy volunteers

Summary

The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) cigarettes on experiences with craving, withdrawal, and pain among individuals with chronic back pain who smoke cigarettes daily.

Description

The goal of this study is to evaluate the effects of very low nicotine content (VLNC) cigarettes on the dynamic associations between smoking, pain, and withdrawal among daily smokers with chronic (> 3 months) non-cancer back pain (n=48). Participants will complete an initial screening session to determine eligibility, followed by a baseline abstinence session in which measures of pain and withdrawal will be assessed following 24 hrs abstinence from smoking. At the conclusion of this session participants will receive training in ecological momentary assessment (EMA) procedures and software will be installed on their smartphone. Participants will then complete a 1-week baseline period, in which they will complete EMA while continuing to smoke usual brand cigarettes. During EMA, participants will receive 6 randomly spaced daily prompts, with 15 questions to complete about smoking behavior, mood, and current pain. In addition, participants will be asked to use their smartphone to indicate whenever they are about to smoke a cigarette. Three of these cigarettes each day will be randomly selected for assessment: in these cases participants will be asked to respond to the same 15 question before and after smoking the cigarette. Participants will also complete end of day questionnaires.

After the 1 week baseline period, participants will be randomly assigned to four weeks of either VLNCs (n=24) or normal nicotine content (NNC) cigarettes (n=24). During this period, participants will be asked to smoke only study cigarettes. Participants will attend weekly laboratory visits to provide biochemical verification of cigarette adherence (urine samples) and complete questionnaires. Study cigarettes will also be provided and collected at these visits. Two of the four weekly urine samples will be selected for analysis. Participants will also complete EMA during weeks 1 and 4 of study cigarette use. End of day questionnaires will continue throughout the 4 weeks.

At the conclusion of the study, participants will attend a final laboratory visit after abstaining from smoking for 24 hours. During this session, self-report measures of pain, craving, and withdrawal will be assessed, along with biochemical verification (breath sample) of abstinence.

Details
Condition Chronic Pain, Smoking, Cigarette
Treatment SPECTRUM NRC 102/103 investigational cigarettes, SPECTRUM NRC 600/601 investigational cigarettes
Clinical Study IdentifierNCT05032755
SponsorDuke University
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

diagnosis of non-cancer chronic (>3 months) back pain (confirmed in medical record or by current provider)
Pain duration of >=3 months with an average intensity of >/= 4/10 as assessed by Graded Chronic Pain Scale (GCPS)
smoking at least 10 cigarettes per day for > 2 years
expired breath CO concentration > 10 ppm
have an iPhone or Android smartphone capable of running EMA software

Exclusion Criteria

actively taking steps to quit smoking
inability to attend all required experimental sessions
report of significant health problems
systolic blood pressure > 160 or diastolic blood pressure > 100
resting heart rate > 100
breath alcohol level > 0.0
current use of opioid pain relievers
lifetime history of bipolar or psychotic disorder
current unstable psychiatric disorder as assessed by the MINI
use of non-cigarette tobacco products > 8 times in the past 30 days
current use of nicotine replacement therapy (NRT) or other smoking cessation strategy
use of Spectrum investigational cigarettes in the past year
quit attempt in the past 30 days resulting in > 3 days abstinence
past year alcohol or substance use disorder
use of illegal drugs as measured by urine drug screen
pain complaint due to specific medical conditions (e.g., cancer, rheumatoid arthritis, complex regional pain syndrome)
spine surgery within the past year or planned surgery within the timeframe of the study
current disability litigation pending
positive pregnancy test among women
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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