Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-04-15
2027-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder
NCT04092101
Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use
NCT02870218
Treatment to Quit Smoking
NCT00018161
Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
NCT00734617
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
NCT00129246
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 Cigarette (NNC) Group
Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks.
Normal Nicotine Cigarettes (NNC)
Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
National Institutes of Health (NIH)
NIH
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maggie Sweitzer, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
North Pavilion
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00116478
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.