Cigarette SmokingPhase 4NCT01932996
Enhancing Smoking Cessation in the Homeless Population
A Phase 4 study testing nicotine patch plus nicotine gum/lozenge and Intensive Alcohol Intervention in people with Cigarette Smoking and Tobacco Smoking, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of this research study is to enhance smoking cessation rates for homeless smokers. The original study design proposed to test the effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will utilize a 3-group randomized design to test study… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Tobacco Smoking, Smoking, Tobacco
- What is being tested?
- nicotine patch plus nicotine gum/lozenge and Intensive Alcohol Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 31 Oct 2018
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently Homeless
- Smoked at least 100 cigarettes in lifetime
- AUDIT score of > or equal to 5, < or equal to 26
- Aged 18 years or older
- Willing to attend study sessions and follow other study protocol
Who cannot join
- Use of smoking cessation medications or interventions in last 30 days
- Unstable medical illness that requires immediate medical care
- AUDIT score of < 5 or > 26
- Pregnancy or other Nicotine Replacement Therapy (NRT) contraindications
- Current history or in past 6 months of psychotic disorder or major depressive disorders that is not stable on treatment for past 3 months
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
The goal of this research study is to enhance smoking cessation rates for homeless smokers. The original study design proposed to test the effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will utilize a 3-group randomized design to test study hypotheses. The three study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A); 2) Intensive Smoking Intervention using CBT-(IS); or 3) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will follows the protocol used in a recent study of alcohol dependent smokers and will include weekly individual sessions for 3 months followed by study data collection visits 3 months. Both study conditions will have equal number of study contacts. Study staff will make retention contacts with participants in the community during weeks that do not have study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16, and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90 days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes, other non-monetary incentives, attractive intervention materials, collaboration with homeless shelters, and advice from a Community Advisory Board. Participants will be enrolled from homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our power calculation indicates that a sample size of 215 per study condition is needed to detect proposed treatment effects.
Read the detailed description
To achieve the study goal, we have selected a 3-group randomized clinical trial (RCT) design that includes 1) Usual Care, 2) Intensive smoking cessation, and 3) Integrated Intensive Smoking and Alcohol Intervention. Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. Having alcohol treatment added to the smoking intervention will enable us assess whether addressing alcohol abuse will result in improved smoking abstinence, an important scientific question that has never been studied in homeless populations.
Study conditions: Both study conditions have identical number of contacts; we considered a design in which the duration of counseling in the UC will be identical to those in the IS+A condition but decided against this because it will create a usual care condition that exceeds standard practice for brief interventions. We understand that testing hypothesis 3 confounds contact time with treatment content, and hence we will not be able to determine that observed differences in outcome are due to specific treatment components. However, given the current state of knowledge about treating homeless alcohol abusing smokers, we believe it is sufficient to show that our intervention led to improved outcome in this group without knowing if the finding is due to specific intervention content. Subsequent research will be needed to disentangle various intervention components.
All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will include weekly individual sessions for 3 months followed by study data collection visits for 3 months. Each participant will be randomly assigned to a condition, which will dictate their treatment. Each participant will be asked to engage in the therapy assigned to their condition, and work to quit smoking and consuming alcohol over a period of one year.
- Conditions
- Cigarette Smoking, Tobacco Smoking, Smoking, Tobacco
- Being tested
- nicotine patch plus nicotine gum/lozenge, Intensive Alcohol Intervention
- Keywords
- Smoking Cessation, Smoking Cessation Products, Tobacco Use Cessation Products
- Medical subject headings
- Cigarette Smoking, Tobacco Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine patch plus nicotine gum/lozengeDrug
Also called NRT
12-week treatment with nicotine patch plus nicotine gum/lozenge
Intensive Alcohol InterventionBehavioural
Also called Cognitive Behavioral Therapy, CBT
Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Integrated Intensive Smoking + Alcohol | Active comparator | IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months. Receives: Drug: nicotine patch plus nicotine gum/lozenge; Behavioral: Intensive Alcohol Intervention |
| Usual Care | Placebo comparator | UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines Receives: Drug: nicotine patch plus nicotine gum/lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
CO-verified Smoking Status at 26 Weeks
Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air. Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.
Measured: 7-day smoking abstinence at week 26 follow-up
Secondary outcomes (1)
CO-verified Smoking Status at 12 Weeks
Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air. Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.
Measured: at weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJan 2015
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
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 (110)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Pratt Rebekah, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932996
- Sponsor's protocol ID
- 1307M39761
- Other IDs
- 2R01HL081522-05A1
- Status last verified
- Nov 2020
- First submitted
- 27 Aug 2013
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kalman D. Smoking cessation treatment for substance misusers in early recovery: a review of the literature and recommendations for practice. Subst Use Misuse. 1998 Aug;33(10):2021-47. doi: 10.3109/10826089809069815.
PubMed 9744841Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
PubMed 3945130Rost K, Burnam MA, Smith GR. Development of screeners for depressive disorders and substance disorder history. Med Care. 1993 Mar;31(3):189-200. doi: 10.1097/00005650-199303000-00001.
PubMed 8450677Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
PubMed 11914441Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short Orientation-Memory-Concentration Test of cognitive impairment. Am J Psychiatry. 1983 Jun;140(6):734-9. doi: 10.1176/ajp.140.6.734.
PubMed 6846631Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. doi: 10.1046/j.1360-0443.2000.9569017.x.
PubMed 10946439DiClemente CC, Carbonari JP, Montgomery RP, Hughes SO. The Alcohol Abstinence Self-Efficacy scale. J Stud Alcohol. 1994 Mar;55(2):141-8. doi: 10.15288/jsa.1994.55.141.
PubMed 8189734Roski J, Schmid LA, Lando HA. Long-term associations of helpful and harmful spousal behaviors with smoking cessation. Addict Behav. 1996 Mar-Apr;21(2):173-85. doi: 10.1016/0306-4603(95)00047-x.
PubMed 8730519Amodei N, Lamb RJ. Convergent and concurrent validity of the Contemplation Ladder and URICA scales. Drug Alcohol Depend. 2004 Mar 8;73(3):301-6. doi: 10.1016/j.drugalcdep.2003.11.005.
PubMed 15036552Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360.
PubMed 1935872Cornoni-Huntley J, Brock D, Ostfeld A, Taylor J, Wallace R. Established populations for for epidemiologic studies of the elderly: Resource data book. Washington, DCL US Department of Health and Human Services; 1986.
Barnes LL, Mendes de Leon CF, Bienias JL, Evans DA. A longitudinal study of black-white differences in social resources. J Gerontol B Psychol Sci Soc Sci. 2004 May;59(3):S146-53. doi: 10.1093/geronb/59.3.s146.
PubMed 15118020Cohen S, Mermelstein R, Kamarck T, Hoberman H, eds. Mesuring the functional components of social support. In Sarason IG, Sarason BR, eds. Social Support: Theory, Research, and Application. The Hague, the Netherlands: Martunus Nijhoff; 1985.
Cohen S, Lichtenstein E. Partner behaviors that support quitting smoking. J Consult Clin Psychol. 1990 Jun;58(3):304-9. doi: 10.1037//0022-006x.58.3.304.
PubMed 2365893
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Smoking Cessation in the Homeless Population
- ClinicalTrials.gov ID
- NCT01932996
- Acronym / sponsor ID
- 1307M39761
- Conditions
- Cigarette Smoking, Tobacco Smoking, Smoking, Tobacco
- Keywords
- Smoking Cessation, Smoking Cessation Products, Tobacco Use Cessation Products
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2015
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to enhance smoking cessation rates for homeless smokers. The original study design proposed to test the effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will utilize a 3-group randomized design to test study hypotheses. The three study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A); 2) Intensive Smoking Intervention using CBT-(IS); or 3) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will follows the protocol used in a recent study of alcohol dependent smokers and will include weekly individual sessions for 3 months followed by study data collection visits 3 months. Both study conditions will have equal number of study contacts. Study staff will make retention contacts with participants in the community during weeks that do not have study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16, and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90 days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes, other non-monetary incentives, attractive intervention materials, collaboration with homeless shelters, and advice from a Community Advisory Board. Participants will be enrolled from homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our power calculation indicates that a sample size of 215 per study condition is needed to detect proposed treatment effects.
Detailed description
To achieve the study goal, we have selected a 3-group randomized clinical trial (RCT) design that includes 1) Usual Care, 2) Intensive smoking cessation, and 3) Integrated Intensive Smoking and Alcohol Intervention. Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. Having alcohol treatment added to the smoking intervention will enable us assess whether addressing alcohol abuse will result in improved smoking abstinence, an important scientific question that has never been studied in homeless populations.
Study conditions: Both study conditions have identical number of contacts; we considered a design in which the duration of counseling in the UC will be identical to those in the IS+A condition but decided against this because it will create a usual care condition that exceeds standard practice for brief interventions. We understand that testing hypothesis 3 confounds contact time with treatment content, and hence we will not be able to determine that observed differences in outcome are due to specific treatment components. However, given the current state of knowledge about treating homeless alcohol abusing smokers, we believe it is sufficient to show that our intervention led to improved outcome in this group without knowing if the finding is due to specific intervention content. Subsequent research will be needed to disentangle various intervention components.
All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will include weekly individual sessions for 3 months followed by study data collection visits for 3 months. Each participant will be randomly assigned to a condition, which will dictate their treatment. Each participant will be asked to engage in the therapy assigned to their condition, and work to quit smoking and consuming alcohol over a period of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Intensive Smoking + Alcohol | Active comparator | Drug: nicotine patch plus nicotine gum/lozenge, Behavioral: Intensive Alcohol InterventionIS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months. |
| Usual Care | Placebo comparator | Drug: nicotine patch plus nicotine gum/lozengeUC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently Homeless
- Smoked at least 100 cigarettes in lifetime
- AUDIT score of > or equal to 5, < or equal to 26
- Aged 18 years or older
- Willing to attend study sessions and follow other study protocol
Key exclusion criteria (6 listed)
- Use of smoking cessation medications or interventions in last 30 days
- Unstable medical illness that requires immediate medical care
- AUDIT score of < 5 or > 26
- Pregnancy or other Nicotine Replacement Therapy (NRT) contraindications
- Current history or in past 6 months of psychotic disorder or major depressive disorders that is not stable on treatment for past 3 months
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 |
|---|---|---|
| nicotine patch plus nicotine gum/lozengeAlso: NRT12-week treatment with nicotine patch plus nicotine gum/lozenge | Drug | Integrated Intensive Smoking + Alcohol, Usual Care |
| Intensive Alcohol InterventionAlso: Cognitive Behavioral Therapy, CBTIntensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months | Behavioural | Integrated Intensive Smoking + Alcohol |
Primary outcome
CO-verified Smoking Status at 26 Weeks
Time frame: 7-day smoking abstinence at week 26 follow-up
Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air. Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.
1 secondary outcome
CO-verified Smoking Status at 12 Weeks
Time frame: at weeks 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9744841Kalman D. Smoking cessation treatment for substance misusers in early recovery: a review of the literature and recommendations for practice. Subst Use Misuse. 1998 Aug;33(10):2021-47. doi: 10.3109/10826089809069815.
- Background: PubMed 3945130Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
- Background: PubMed 8450677Rost K, Burnam MA, Smith GR. Development of screeners for depressive disorders and substance disorder history. Med Care. 1993 Mar;31(3):189-200. doi: 10.1097/00005650-199303000-00001.
- Background: PubMed 11914441Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
- Background: PubMed 6846631Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short Orientation-Memory-Concentration Test of cognitive impairment. Am J Psychiatry. 1983 Jun;140(6):734-9. doi: 10.1176/ajp.140.6.734.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 10946439Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. doi: 10.1046/j.1360-0443.2000.9569017.x.
- Background: PubMed 8189734DiClemente CC, Carbonari JP, Montgomery RP, Hughes SO. The Alcohol Abstinence Self-Efficacy scale. J Stud Alcohol. 1994 Mar;55(2):141-8. doi: 10.15288/jsa.1994.55.141.
- Background: PubMed 8730519Roski J, Schmid LA, Lando HA. Long-term associations of helpful and harmful spousal behaviors with smoking cessation. Addict Behav. 1996 Mar-Apr;21(2):173-85. doi: 10.1016/0306-4603(95)00047-x.
- Background: PubMed 15036552Amodei N, Lamb RJ. Convergent and concurrent validity of the Contemplation Ladder and URICA scales. Drug Alcohol Depend. 2004 Mar 8;73(3):301-6. doi: 10.1016/j.drugalcdep.2003.11.005.
- Background: PubMed 1935872Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360.
- BackgroundCornoni-Huntley J, Brock D, Ostfeld A, Taylor J, Wallace R. Established populations for for epidemiologic studies of the elderly: Resource data book. Washington, DCL US Department of Health and Human Services; 1986.
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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.
Pratt Rebekah, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nicotine patch plus nicotine gum/lozenge and Intensive Alcohol Intervention in people with Cigarette Smoking and Tobacco Smoking, run by University of Minnesota at 1 site 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 5 inclusion and 6 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Nov 2020). 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?
CO-verified Smoking Status at 26 Weeks (time frame: 7-day smoking abstinence at week 26 follow-up). 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 NCT01932996, which also lists 110 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 19 Nov 2020.