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 craving, withdrawal, and pain among individuals with chronic pain who smoke cigarettes daily and are attending office-based buprenorphine treatment (OBBT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
60
Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco.
Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco.
North Pavilion
Durham, North Carolina, United States
RECRUITINGNicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)
The FTCD has a total score of 0 to 10, where a greater score indicates a greater physical dependence on nicotine.
Time frame: Baseline and weekly during study cigarette use (4 weeks)
Cigarettes per Day
Average cigarettes smoked per day during the past week will be calculated using timeline follow-back methods
Time frame: Baseline and weekly during study cigarette use (4 weeks)
Pain as measured by the Brief Pain Inventory (BPI)
The BPI has an averaged score of 0 to 10, where a greater score indicates greater pain.
Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
Mechanical Hyperalgesia
Mechanical hyperalgesia is a condition that causes increased sensitivity to mechanical stimuli after an injury to the skin. Discriminability and response bias will be assessed using a computerized pressure algometer.
Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Smoking Withdrawal as measured by the Minnesota Withdrawal Scale (MNWS)
The MNWS has a total score range of 0 to 68, where a higher score indicates greater symptoms of withdrawal.
Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
Cigarette Craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-B)
The QSU-B has a total score range of 0 to 100, where a higher score indicates greater craving.
Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
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Cigarette Purchase Task - demand intensity
Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).
Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Cigarette Purchase Task - Omax
Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).
Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA)
EMA (also called experience sampling or daily diary method) involves repeated sampling of people's current experiences (e.g. pain) in real time in their natural environments.
Time frame: Baseline, weeks 1 and 4 of study cigarette use
Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency
Within-person variability in smoking frequency assessed via EMA before and after buprenorphine administration.
Time frame: Baseline, weeks 1 and 4 of study cigarette use
Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - craving
Within-person variability in smoking craving assessed via EMA before and after buprenorphine administration.
Time frame: Baseline, weeks 1 and 4 of study cigarette use
Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)
The SOWS consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0-not at all, 1-a little, 2-moderately, 3-quite a bit, 4-extremely. The total score ranges from 0 to 64, where a higher score indicates greater symptoms of withdrawal.
Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
Number of participants willing to Quit Smoking
Decision (yes/no) to engage in the optional quit attempt
Time frame: post-intervention, after 24 hrs abstinence
Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ)
The SEQ has a total score range of 10 to 40, where a higher score indicates greater self-efficacy.
Time frame: Weekly visits 1 and 5
Pain and Smoking Inventory (PSI)
The PSI total score is computed by averaging scores across the nine items. Items are endorsed on a seven-point Likert scale anchored at 0 (not true at all), 3 (somewhat true), and 6 (extremely true). Scores range from 0 to 6, where higher scores indicate greater perceptions that pain and smoking are interrelated.
Time frame: Weekly visits 1 and 5
Barriers to Quitting Smoking in Substance Abuse Treatment (BSQ-SAT)
The BQS-SAT is an 11-item true-false instrument of perceived barriers to quitting smoking plus one open-ended item. The score can range from 0 to 4.86, where a higher score indicates a greater perceived barrier.
Time frame: Weekly visits 1 and 5