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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA060477-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very Low Nicotine Cigarette (VLNC) Group | Experimental | Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks. |
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| Normal Nicotine Cigarette (NNC) Group | Active Comparator | Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very Low Nicotine Cigarettes (VLNC) | Behavioral | Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco. |
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| Measure | Description | Time Frame |
|---|---|---|
| Nicotine 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. | 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 | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants willing to Quit Smoking | Decision (yes/no) to engage in the optional quit attempt | post-intervention, after 24 hrs abstinence |
| Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | 919-907-9955 | ta141@duke.edu | |
| Clinical Research Coordinator | Contact | 984-327-6157 | lgf12@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maggie Sweitzer, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Pavilion | Recruiting | Durham | North Carolina | 27705 | United States |
The final dataset will include demographic, interview and self-report data. The investigators will share de-identified individual-participant level (IPD) data. Appropriate measures will be used for data de-identification and sharing, and informed consent will reflect those plans.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Normal Nicotine Cigarettes (NNC) | Behavioral | Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco. |
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| Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks) |
| 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). | 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). | 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. | 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. | 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. | 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. | Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks) |
The SEQ has a total score range of 10 to 40, where a higher score indicates greater self-efficacy.
| 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. | 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. | Weekly visits 1 and 5 |
| D001519 | Behavior |