Opioids, Low Nicotine Cigarettes, and Chronic Pain

BEHAVIORAL

Very Low Nicotine Cigarettes (VLNC)

Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco.

BEHAVIORAL

Normal Nicotine Cigarettes (NNC)

Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco.

Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)

Time frame: Baseline and weekly during study cigarette use (4 weeks)

The FTCD has a total score of 0 to 10, where a greater score indicates a greater physical dependence on nicotine.

Cigarettes per Day

Time frame: Baseline and weekly during study cigarette use (4 weeks)

Average cigarettes smoked per day during the past week will be calculated using timeline follow-back methods

Pain as measured by the Brief Pain Inventory (BPI)

Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)

The BPI has an averaged score of 0 to 10, where a greater score indicates greater pain.

Mechanical Hyperalgesia

Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions

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.

Smoking Withdrawal as measured by the Minnesota Withdrawal Scale (MNWS)

Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)

The MNWS has a total score range of 0 to 68, where a higher score indicates greater symptoms of withdrawal.

Cigarette Craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-B)

Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)

The QSU-B has a total score range of 0 to 100, where a higher score indicates greater craving.

Cigarette Purchase Task - demand intensity

Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions

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).

Cigarette Purchase Task - Omax

Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions

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).

Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA)

Time frame: Baseline, weeks 1 and 4 of study cigarette use

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.

Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency

Time frame: Baseline, weeks 1 and 4 of study cigarette use

Within-person variability in smoking frequency assessed via EMA before and after buprenorphine administration.

Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - craving

Time frame: Baseline, weeks 1 and 4 of study cigarette use

Within-person variability in smoking craving assessed via EMA before and after buprenorphine administration.

Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)

Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.