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

Duke University

Status: Completed

Conditions: Smoking, Cigarette; Chronic Pain

Treatments: Other: SPECTRUM NRC 600/601 investigational cigarettes; Other: SPECTRUM NRC 102/103 investigational cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05032755

R21DA052729 (U.S. NIH Grant/Contract)

Pro00108705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

VLNC Group

Experimental group

Description:

Participants in this condition will be provided with Spectrum NRC102/103 (nonmenthol/menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco with reported nicotine yield (ISO) of 0.03 +/- 0.01 mg and a tar yield of 9 +/- 1.5. Participants will be asked to smoke only study cigarettes for 4 weeks.

Treatment:

Other: SPECTRUM NRC 102/103 investigational cigarettes

NNC Group

Active Comparator group

Description:

Participants in this condition will be provided with Spectrum NRC600/601 (non-menthol/menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco with reported nicotine yield (ISO) of 0.8 +/- 0.15 mg and a tar yield of 10.5 +/- 1.5.

Treatment:

Other: SPECTRUM NRC 600/601 investigational cigarettes