Clinical trial NCT05032755: Low Nicotine Cigarettes, Smoking, and Chronic Pain
Official title: Using Very Low Nicotine Cigarettes to Disrupt the Pain-smoking Reinforcement Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Smoking, Cigarette
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-02
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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 or worst pain \>/=6/10 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

Primary outcomes:
measure: Change in dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)
timeFrame: Baseline, weekly for 5 weeks
measure: Changes in abstinence-induced cigarette withdrawal as measured by the Minnesota Tobacco Withdrawal Scale (MNWS)
timeFrame: Baseline abstinence session, follow-up abstinence session (immediately after 4 weeks of cigarette use)
measure: Weekly changes in withdrawal symptoms as measured by the Minnesota Tobacco Withdrawal Scale
timeFrame: Weekly for 5 visits
measure: Changes in abstinence-induced craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
timeFrame: Baseline abstinence session, follow-up abstinence session (immediately after 4 weeks of cigarette use)
measure: Weekly changes in craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
timeFrame: Weekly for 5 visits
measure: Changes in pain intensity and interference during smoking abstinence as measured by the past 24-hour version of the Brief Pain Inventory (BPI)
timeFrame: aseline abstinence session, follow-up abstinence session (immediately after 4 weeks of cigarette use)
measure: Weekly changes in pain intensity and interference as measured by the past-week version of the Brief Pain Inventory (BPI)
timeFrame: Weekly for 5 visits
Secondary outcomes:
measure: Changes in smoking abstinence self-efficacy as measured by the Smoking Self-Efficacy Questionnaire (SEQ-12)
timeFrame: Weekly visits 1 and 5
measure: Changes in motivation to quit smoking as measured by the Contemplation Ladder
timeFrame: Weekly visits 1 and 5
measure: Changes in smoking to cope with pain as measured by the Pain and Smoking Inventory (PSI)
timeFrame: Weekly visits 1 and 5
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Maggie Sweitzer
role: PRINCIPAL_INVESTIGATOR
References: