Tobacco Use DisorderPhase 1/2NCT02250534
Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
A Phase 1/2 study testing Very low nicotine content cigarettes in people with Tobacco Use Disorder, run by University of Vermont at 2 sites in United States.
Trial summary
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Very low nicotine content cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 775 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to Oct 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Ages 18-44 years
- Less than an Associate's degree
- Report smoking ≥ 5 cigarettes per day
- Provide an intake breath carbon monoxide (CO) sample > 8 ppm
- Be without current (within the past year) serious mental disorder that would interfere with study results or completion as determined by the Licensed Medical Professional or PI
Show all 11Show fewer
- Be without current substance abuse/dependence other than nicotine
- Be sufficiently literate to complete research-related tasks
- Be in good physical health without serious illness or change in health or medication in the past three months as determined by the Licensed Medical Professional at each site
- Not pregnant or nursing and report using oral, implant, patch, ring, intrauterine device (IUD), injection, or barrier contraceptives or report being surgically sterile, or post menopausal
- Report no significant use of other tobacco or nicotine products within the past month (> 9 days in the past 30)
Who cannot join
- Any prior regular use (used as primary cigarette outside of the laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content)
- Exclusive use of roll-your-own cigarettes
- Planning to quit smoking in the next 30 days
- A quit attempt in the past 30 days resulting in > 3 days of abstinence
- Currently taking anticonvulsant medications
- Positive toxicology screen for illicit drugs not including marijuana (participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once)
Show all 18Show fewer
- Breath alcohol level > 0.01 (participants with a positive screen will be allowed to re-screen once)
- Self-report of binge drinking alcohol (> 9 days in past 30, 4 drinks in 2 hours )
- Systolic blood pressure < 90 or ≥ 160 mmHg (participants outside the range will be allowed to re-screen once)
- Diastolic blood pressure < 50 or ≥ 100 mmHg (participants outside the range will be allowed to re-screen once)
- Breath CO > 80 ppm
- Heart rate < 45 or ≥ 115 bpm (participants outside the range will be allowed to re-screen once)
- Currently seeking treatment for smoking cessation
- Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion for treatment of depression will be allowed)
- Current symptoms of psychosis, dementia or mania
- Suicidal ideation in the past month
- Suicide attempt in past 6 months
- Participation in another research study in the past 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21224
University of Vermont
Burlington, Vermont, 05401
About this study
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including cervical cancer, thrombosis related to hormone-based contraception, infertility, and early menopause. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like disadvantaged women who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.
Read the detailed description
The primary overall objective of these studies is to evaluate the effects of extended exposure to cigarettes differing in nicotine content in socioeconomically disadvantaged (< high school educational attainment) women of childbearing age using a 3-condition, parallel groups design. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly assigned to one of three cigarette conditions (nicotine content: 0.04, 2.4, and 15.8 mg nicotine/gram of tobacco) for the 12-week experimental period.
The cigarettes to be used in this study were made under an NIH contract with production being overseen by the Research Triangle Institute (referred to as "Spectrum cigarettes"). NIH currently has approximately 10 million of these cigarettes (of varying types) for research purposes. The cigarettes selected for the study span the range of yields likely to produce the hypothesized effects, as described above. The Spectrum cigarettes are not currently commercially available, although they are similar in many ways to marketed cigarettes (e.g., similar manufacturing, filter, paper, etc.).
The primary overall objective of this study is to evaluate the effects of extended exposure to cigarettes differing in nicotine content in female adult smokers of childbearing age (18-44 yrs) whose highest academic degree is high school using a 3-condition, parallel groups design. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly assigned to one of three cigarette conditions (nicotine content: 0.04 mg, 2.4 mg, and 15.8 mg nicotine/g of tobacco) for the 12-week experimental period.
Participants will be seen weekly throughout the 12-week experimental period to obtain research cigarettes. Cigarettes smoked per day will be obtained by participants completing daily Interactive Voice Response (IVR) reports of cigarettes in past 24 hours. This daily data will be used to calculate weekly means, with week-12 means serving as the primary outcome.
This same study was conducted in two additional vulnerable populations under a similar protocol, with differences between protocols consisting of data collection specific to that vulnerable population. This included information such as use and timing of opioid maintenance therapy for individuals with opioid-use disorder or additional assessments of anxiety and depression for individuals with affective disorders. In order to explore potential differences across individuals with different vulnerabilities, data from all three studies were combined for analysis. A vulnerable population-by-condition or population-by-condition-by-time interaction term was included in all analyses. In the event that these interaction terms were statistically significant, all pairwise comparisons were conducted using a Bonferroni multiple comparison adjustment.
- Conditions
- Tobacco Use Disorder
- Being tested
- Very low nicotine content cigarettes
- Keywords
- Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Women, Health disparities, Vulnerable populations
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low nicotine content cigarettesOther
| Study group | Role | What they receive |
|---|---|---|
| 0.8 mg nicotine | Experimental | 0.8 mg nicotine very low nicotine content cigarettes Receives: Other: Very low nicotine content cigarettes |
| 0.12 mg nicotine | Experimental | 0.12 mg nicotine very low nicotine content cigarettes Receives: Other: Very low nicotine content cigarettes |
| 0.03 mg nicotine | Experimental | 0.03 mg nicotine very low nicotine content cigarettes Receives: Other: Very low nicotine content cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarettes Per Day (CPD)
Participant reported number of cigarettes smoked per day at Week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startOct 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was one of three multi-site clinical trials conducted in three different vulnerable populations under a similar protocol, with differences between protocols consisting of data collection specific to that vulnerable population. This included information such as use and timing of opioid maintenance therapy for individuals with opioid-use disorder or additional assessments of anxiety and depression for individuals with affective disorders. In order to explore potential differences across individuals with different vulnerabilities, data from all three studies were combined for analysis. A vulnerable population-by-condition or population-by- condition-by-time interaction term was included in all analyses. In the event that these interaction terms were statistically significant, all pairwise comparisons were conducted using a Bonferroni multiple comparison adjustment. Please see Statistical Analysis Plan for more details.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 775 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Stephen T. Higgins, PhD, University of Vermont
- Investigators
- Stephen T. Higgins, Ph.D., Study director, University of VermontSarah H. Heil, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250534
- Sponsor's protocol ID
- P50DA036114:P1S2
- Other IDs
- P50DA036114
- Status last verified
- Nov 2022
- First submitted
- 23 Sep 2014
- Last updated
- 1 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nolder KA, Erath TG, DeSarno MJ, Klemperer EM, Higgins ST. A further examination of the validity of assessing demand intensity using the Cigarette Purchase Task. Exp Clin Psychopharmacol. 2026 Aug 6:10.1037/pha0000874. doi: 10.1037/pha0000874. Online ahead of print.
PubMed 42560883Harfmann RF, Heil SH, Bunn JY, Snell LM, Tidey JW, Sigmon SC, Gaalema DE, Lee DC, Streck JM, Bergeria CL, Davis DR, Plucinski S, Higgins ST. Changes in weight among individuals with psychiatric conditions or socioeconomic disadvantage assigned to smoke very low nicotine content cigarettes. Exp Clin Psychopharmacol. 2024 Apr;32(2):181-188. doi: 10.1037/pha0000700. Epub 2024 Jan 18.
PubMed 38236223Gaalema DE, Snell LM, Tidey JW, Sigmon SC, Heil SH, Lee DC, Bunn JY, Park C, Hughes JR, Higgins ST. Potential effects of nicotine content in cigarettes on use of other substances. Prev Med. 2022 Dec;165(Pt B):107290. doi: 10.1016/j.ypmed.2022.107290. Epub 2022 Oct 5.
PubMed 36208817Oliver AC, DeSarno M, Irvin CG, Kaminsky D, Tidey JW, Sigmon SC, Heil SH, Gaalema DE, Lee D, Bunn JY, Davis DR, Streck JM, Gallagher T, Higgins ST. Effects of Reduced Nicotine Content Cigarettes on Fractional Exhaled Nitric Oxide and Self-Reported Respiratory Health Outcomes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage. Nicotine Tob Res. 2022 Jan 1;24(1):135-140. doi: 10.1093/ntr/ntab145.
PubMed 34255068Higgins ST, DeSarno M, Bunn JY, Gaalema DE, Leventhal AM, Davis DR, Streck JM, Harfmann RF, Markesich C, Orr E, Sigmon SC, Heil SH, Tidey JW, Lee D, Hughes JR. Cumulative vulnerabilities as a potential moderator of response to reduced nicotine content cigarettes. Prev Med. 2021 Nov;152(Pt 2):106714. doi: 10.1016/j.ypmed.2021.106714. Epub 2021 Jul 7.
PubMed 34242666Higgins ST, Tidey JW, Sigmon SC, Heil SH, Gaalema DE, Lee D, Hughes JR, Villanti AC, Bunn JY, Davis DR, Bergeria CL, Streck JM, Parker MA, Miller ME, DeSarno M, Priest JS, Cioe P, MacLeod D, Barrows A, Markesich C, Harfmann RF. Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage: 3 Randomized Clinical Trials. JAMA Netw Open. 2020 Oct 1;3(10):e2019311. doi: 10.1001/jamanetworkopen.2020.19311.
PubMed 33079196Higgins ST, DeSarno M, Davis DR, Nighbor T, Streck JM, Adise S, Harfmann R, Nesheim-Case R, Markesich C, Reed D, Tyndale RF, Gaalema DE, Heil SH, Sigmon SC, Tidey JW, Villanti AC, Lee D, Hughes JR, Bunn JY. Relating individual differences in nicotine dependence severity to underpinning motivational and pharmacological processes among smokers from vulnerable populations. Prev Med. 2020 Nov;140:106189. doi: 10.1016/j.ypmed.2020.106189. Epub 2020 Jul 3.
PubMed 32628945
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
- ClinicalTrials.gov ID
- NCT02250534
- Acronym / sponsor ID
- P50DA036114:P1S2
- Conditions
- Tobacco Use Disorder
- Keywords
- Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Women, Health disparities, Vulnerable populations
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 775 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Posted 1 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including cervical cancer, thrombosis related to hormone-based contraception, infertility, and early menopause. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like disadvantaged women who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.
Detailed description
The primary overall objective of these studies is to evaluate the effects of extended exposure to cigarettes differing in nicotine content in socioeconomically disadvantaged (< high school educational attainment) women of childbearing age using a 3-condition, parallel groups design. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly assigned to one of three cigarette conditions (nicotine content: 0.04, 2.4, and 15.8 mg nicotine/gram of tobacco) for the 12-week experimental period.
The cigarettes to be used in this study were made under an NIH contract with production being overseen by the Research Triangle Institute (referred to as "Spectrum cigarettes"). NIH currently has approximately 10 million of these cigarettes (of varying types) for research purposes. The cigarettes selected for the study span the range of yields likely to produce the hypothesized effects, as described above. The Spectrum cigarettes are not currently commercially available, although they are similar in many ways to marketed cigarettes (e.g., similar manufacturing, filter, paper, etc.).
The primary overall objective of this study is to evaluate the effects of extended exposure to cigarettes differing in nicotine content in female adult smokers of childbearing age (18-44 yrs) whose highest academic degree is high school using a 3-condition, parallel groups design. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly assigned to one of three cigarette conditions (nicotine content: 0.04 mg, 2.4 mg, and 15.8 mg nicotine/g of tobacco) for the 12-week experimental period.
Participants will be seen weekly throughout the 12-week experimental period to obtain research cigarettes. Cigarettes smoked per day will be obtained by participants completing daily Interactive Voice Response (IVR) reports of cigarettes in past 24 hours. This daily data will be used to calculate weekly means, with week-12 means serving as the primary outcome.
This same study was conducted in two additional vulnerable populations under a similar protocol, with differences between protocols consisting of data collection specific to that vulnerable population. This included information such as use and timing of opioid maintenance therapy for individuals with opioid-use disorder or additional assessments of anxiety and depression for individuals with affective disorders. In order to explore potential differences across individuals with different vulnerabilities, data from all three studies were combined for analysis. A vulnerable population-by-condition or population-by-condition-by-time interaction term was included in all analyses. In the event that these interaction terms were statistically significant, all pairwise comparisons were conducted using a Bonferroni multiple comparison adjustment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study was one of three multi-site clinical trials conducted in three different vulnerable populations under a similar protocol, with differences between protocols consisting of data collection specific to that vulnerable population. This included information such as use and timing of opioid maintenance therapy for individuals with opioid-use disorder or additional assessments of anxiety and depression for individuals with affective disorders. In order to explore potential differences across individuals with different vulnerabilities, data from all three studies were combined for analysis. A vulnerable population-by-condition or population-by- condition-by-time interaction term was included in all analyses. In the event that these interaction terms were statistically significant, all pairwise comparisons were conducted using a Bonferroni multiple comparison adjustment. Please see Statistical Analysis Plan for more details.
| Arm | Type | Receives |
|---|---|---|
| 0.8 mg nicotine | Experimental | Other: Very low nicotine content cigarettes0.8 mg nicotine very low nicotine content cigarettes |
| 0.12 mg nicotine | Experimental | Other: Very low nicotine content cigarettes0.12 mg nicotine very low nicotine content cigarettes |
| 0.03 mg nicotine | Experimental | Other: Very low nicotine content cigarettes0.03 mg nicotine very low nicotine content cigarettes |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female
- Ages 18-44 years
- Less than an Associate's degree
- Report smoking ≥ 5 cigarettes per day
- Provide an intake breath carbon monoxide (CO) sample > 8 ppm
Key exclusion criteria (18 listed)
- Any prior regular use (used as primary cigarette outside of the laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content)
- Exclusive use of roll-your-own cigarettes
- Planning to quit smoking in the next 30 days
- A quit attempt in the past 30 days resulting in > 3 days of abstinence
- Currently taking anticonvulsant medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low nicotine content cigarettes | Other | 0.03 mg nicotine, 0.12 mg nicotine, 0.8 mg nicotine |
Primary outcome
Cigarettes Per Day (CPD)
Time frame: 12 weeks
Participant reported number of cigarettes smoked per day at Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42560883Nolder KA, Erath TG, DeSarno MJ, Klemperer EM, Higgins ST. A further examination of the validity of assessing demand intensity using the Cigarette Purchase Task. Exp Clin Psychopharmacol. 2026 Aug 6:10.1037/pha0000874. doi: 10.1037/pha0000874. Online ahead of print.
- Derived from this study: PubMed 38236223Harfmann RF, Heil SH, Bunn JY, Snell LM, Tidey JW, Sigmon SC, Gaalema DE, Lee DC, Streck JM, Bergeria CL, Davis DR, Plucinski S, Higgins ST. Changes in weight among individuals with psychiatric conditions or socioeconomic disadvantage assigned to smoke very low nicotine content cigarettes. Exp Clin Psychopharmacol. 2024 Apr;32(2):181-188. doi: 10.1037/pha0000700. Epub 2024 Jan 18.
- Derived from this study: PubMed 36208817Gaalema DE, Snell LM, Tidey JW, Sigmon SC, Heil SH, Lee DC, Bunn JY, Park C, Hughes JR, Higgins ST. Potential effects of nicotine content in cigarettes on use of other substances. Prev Med. 2022 Dec;165(Pt B):107290. doi: 10.1016/j.ypmed.2022.107290. Epub 2022 Oct 5.
- Derived from this study: PubMed 34255068Oliver AC, DeSarno M, Irvin CG, Kaminsky D, Tidey JW, Sigmon SC, Heil SH, Gaalema DE, Lee D, Bunn JY, Davis DR, Streck JM, Gallagher T, Higgins ST. Effects of Reduced Nicotine Content Cigarettes on Fractional Exhaled Nitric Oxide and Self-Reported Respiratory Health Outcomes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage. Nicotine Tob Res. 2022 Jan 1;24(1):135-140. doi: 10.1093/ntr/ntab145.
- Derived from this study: PubMed 34242666Higgins ST, DeSarno M, Bunn JY, Gaalema DE, Leventhal AM, Davis DR, Streck JM, Harfmann RF, Markesich C, Orr E, Sigmon SC, Heil SH, Tidey JW, Lee D, Hughes JR. Cumulative vulnerabilities as a potential moderator of response to reduced nicotine content cigarettes. Prev Med. 2021 Nov;152(Pt 2):106714. doi: 10.1016/j.ypmed.2021.106714. Epub 2021 Jul 7.
- Derived from this study: PubMed 33079196Higgins ST, Tidey JW, Sigmon SC, Heil SH, Gaalema DE, Lee D, Hughes JR, Villanti AC, Bunn JY, Davis DR, Bergeria CL, Streck JM, Parker MA, Miller ME, DeSarno M, Priest JS, Cioe P, MacLeod D, Barrows A, Markesich C, Harfmann RF. Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage: 3 Randomized Clinical Trials. JAMA Netw Open. 2020 Oct 1;3(10):e2019311. doi: 10.1001/jamanetworkopen.2020.19311.
- Derived from this study: PubMed 32628945Higgins ST, DeSarno M, Davis DR, Nighbor T, Streck JM, Adise S, Harfmann R, Nesheim-Case R, Markesich C, Reed D, Tyndale RF, Gaalema DE, Heil SH, Sigmon SC, Tidey JW, Villanti AC, Lee D, Hughes JR, Bunn JY. Relating individual differences in nicotine dependence severity to underpinning motivational and pharmacological processes among smokers from vulnerable populations. Prev Med. 2020 Nov;140:106189. doi: 10.1016/j.ypmed.2020.106189. Epub 2020 Jul 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen T. Higgins, Ph.D. study director
University of Vermont
Sarah H. Heil, Ph.D. principal investigator
University of Vermont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Very low nicotine content cigarettes in people with Tobacco Use Disorder, run by University of Vermont at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarettes Per Day (CPD) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02250534, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.