Recruiting

Opioids & Low Nicotine Cigarettes

Sponsor:

Duke University

Code:

NCT06747871

Conditions

Chronic Pain

Tobacco Use

Opioid Substitution Treatment

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Very Low Nicotine Cigarettes (VLNC)

Normal Nicotine Cigarettes (NNC)

Study Details

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 craving, withdrawal, and pain among individuals with chronic pain who smoke cigarettes daily and are attending office-based buprenorphine treatment (OBBT).

Conditions

Chronic Pain

Tobacco Use

Opioid Substitution Treatment

Study ID

NCT06747871

Start date

Apr 15, 2025

Status verified date

Jan, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 21+ years who smoke cigarettes daily
  • Chronic non-cancer musculoskeletal pain secondary to structural changes (e.g., low back pain, osteoarthritis)
  • Have received stable office-based buprenorphine treatment for opioid use disorder for at least 30 days
  • Self-report smoking at least 10 cigarettes/day
  • Expired breath carbon monoxide (CO) level >8 ppm
  • Have a smartphone capable of running software for ecological momentary assessment
  • Open to exploring the possibility of quitting smoking

Exclusion Criteria:

  • Pain specifically due to cancer
  • Other significant health problems
  • Major surgery within the past 6 months or planned surgery within the timeframe of the study
  • Current disability litigation
  • Use of electronic cigarettes or other non-cigarette tobacco products > 9 of the past 30 days
  • Current use of nicotine replacement therapy or other cessation treatment
  • Current daily or near-daily cannabis use
  • History of psychotic disorder
  • Acute suicidality or current unstable psychiatric disorder
  • Positive pregnancy test
  • Actively seeking smoking cessation treatment

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Very Low Nicotine Cigarette (VLNC) Group

Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks.

active comparator: Normal Nicotine Cigarette (NNC) Group

Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks.

Interventions

Very Low Nicotine Cigarettes (VLNC)

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

Normal Nicotine Cigarettes (NNC)

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

Primary outcome measure

  • Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD) [ Time Frame: Baseline and weekly during study cigarette use (4 weeks) ]
  • Cigarettes per Day [ Time Frame: Baseline and weekly during study cigarette use (4 weeks) ]
  • 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) ]
  • Mechanical Hyperalgesia [ 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) [ 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) [ Time Frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks) ]
  • Cigarette Purchase Task - demand intensity [ Time Frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions ]
  • Cigarette Purchase Task - Omax [ 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) [ Time Frame: Baseline, weeks 1 and 4 of study cigarette use ]
  • Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency [ Time Frame: Baseline, weeks 1 and 4 of study cigarette use ]
  • Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - craving [ Time Frame: Baseline, weeks 1 and 4 of study cigarette use ]
  • 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) ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

919-907-9955ta141@duke.edu

Clinical Research Coordinator

984-327-6157lgf12@duke.edu

Locations

North Pavilion

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Clinical Research Coordinator

919-907-9955sweitzerlab@duke.edu

More Information

Sponsor

Duke University

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.