2025-07-07
minor
Study Status, Contacts/Locations v25
Primary completion date2025-06-30→2025-08-31
Completion date2025-06-30→2025-08-31
Show 22 earlier versions
2024-05-16
minor
Study Status, Eligibility v22
Primary completion date2024-06-01→2025-06-30
Completion date2024-06-01→2025-06-30
Eligibility criteria+5 characters
Inclusion Criteria:
Age: 18-75 years old
• Smoking 5 or more cigarettes, littleLittle cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbonCO monoxide≥ (CO)6ppm greater than or equal to 6 parts per million (ppm).
(if </=≤ 5, then NicAlert Strip >2).
Interested in treatment that mi [...] the only participant in their household
Exclusion Criteria:
Standard criteria for transdermal nicotine and varenicline smoking cessation trials will be used.
Exclusion criteria will include the following:
Within the month immediately preceding the screening [...] [...]
2024-05-08
minor
2 amendments v20-v21
2 re-verifications since 2023-11-03, no change to tracked fields
2023-05-22
minor
Study Status v19
Primary completion date2023-06-01→2024-06-01
Completion date2023-06-01→2024-06-01
2022-06-15
minor
Study Status v18
Primary completion date2021-06-01→2023-06-01
Completion date2021-06-01→2023-06-01
2021-03-24
minor
Study Status v17
Primary completion date2019-12→2021-06-01
Completion date2020-12→2021-06-01
2019-05-16
minor
Study Status v16
Re-verified, no change to tracked fields
2018-01-29
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Completion date2019-12→2020-12
Start date2015-12→2015-12-14
Enrollment targetestimated 170→confirmed 204
Study sitesdetails revised at 1 of 1 site
2017-09-14
minor
Study Status v14
Re-verified, no change to tracked fields
2017-06-26
minor
Study Status, Study Description, Eligibility v13
Eligibility criteria+208 characters
Inclusion Criteria:
Age: 18-75 years old
Smoking 5 or more cigarettes or, little cigars or cigarillos per day, on average, within the 2 months preceding the scre [...] t, use of any form of tobacco products other than cigarettes or, little cigars or cigarillos on 3 or more days within a week if the individual refuses t [...] ast 6 months only; current substance dependence), K (current/lifetime psychotic disorder or current/lifetime mood disorder with psychotic features).
Individuals who mee [...] in, they will not be allowed to return.
Must not have visual or auditory problems that in the investigators opinion wou [...] [...]
Study description+196 characters
[...] study staff will be able to find out what you are receiving (called "unblinding").
Once the study has ended and the Data Safety Monitoring Board (DSMB) at MD Anderson has granted approval, you may be unblinded at your request.
Study Drug Administration:
You will start taking your assign [...] will take about 15 minutes each.
At Visits 1, 4 and 6:
Urine or saliva will be collected for a routine test to check your cotinine [...] will be drawn to check your liver and kidney function.
Urine or saliva will be collected to measure your nicotine, anabasine, and [...] res will be performed:
Your CO level will be measure [...]
2017-02-08
minor
Study Status v12
Re-verified, no change to tracked fields
2017-02-07
minor
Study Status, Oversight v11
Completion datenot stated→2019-12
2016-09-08
minor
5 amendments v6-v10
5 re-verifications since 2016-04-04, no change to tracked fields
2016-03-31
minor
Study Status, Study Description, Arms and Interventions, Eligibility v5
Eligibility criteria-115 characters
[...] to Varenicline, NRT, or any component of these formulations (including allergy to latex).
Any medical or psychiatric condition, illness, disorder, o [...] ey test positive again, they will not be allowed to return.
Head injury with loss of consciousness (within 5 years as established by self-report)
Must not have visual or auditory problems that in the invest [...]
Study description+906 characters
Study Groups:
If you are found to be eligibleagree to take part in this study, you will be randomly assigned ( [...] signed study drug(s) the day after Visit 1.
You should take Vareniclinevarenicline/Placeboplacebo tablets by mouth with a cup (8 ounces) of water after eatin [...] dy staff at each study visit.
You should apply the nicotine/Placeboplacebo patch to the upper arm.
You should put it in a slightly dif [...] ions will take about 15 minutes each.
At Visits 1, 4 and 6:
SalivaUrine will be collected for a routine test to check your cotinine, nicotine, and anabasine levels.
Cotinine is a chemical released in [...] [...]
2015-12-14
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2015-08-07
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Eligibility v3
Primary completion date2019-04→2019-12
Start date2015-04→2015-12
Enrollment target90→170
Eligibility criteria+33 characters
Inclusion Criteria:
Age: 18-6575 years old.
Smoking 5 or more cigarettes or little cigars per day, on average, within the 2 months preceding the scre [...] t, use of any form of tobacco products other than cigarettes or little cigars on 3 or more days within a week if the individual refuses t [...]
Study description-350 characters
Study Groups:
If participantyou isare found to be eligible to take part in this study, theyyou will be randomly assigned (as in the roll of a dice) to 1 o [...] y group is better, the same, or worse than the other group.
ParticipantYou will have an equal chance of being assigned to Group 1 or 2.
If participantyou isare in Group 1, theyyou will receive varenicline and a placebo patch.
A placebo is [...] udy drug to learn if the study drug has any real effect.
If participantyou isare in Group 2, theyyou will receive an active nicotine patch and a placebo tablet.
Neither participantyou nor the study doctor wi [...] [...]
Collaborators+17 characters
NAL PHARMA
Pfizer
2015-02-24
minor
Study Status, Study Description, Arms and Interventions, Eligibility v2
Eligibility criteria+578 characters
Inclusion Criteria:
Age: 18-65 years old.
Smoking 5 or more cigarettes per day, on average, within th [...] de (CO) greater than or equal to 6 parts per million (ppm).
(if </= 5, then NicAlert Strip >2).
Interested in treatment that might change smoking behavior
A [...] to all assessments and study procedures
Have an address and home telephone number where they may be reached
Be the only part [...] in the next 12 months
Plan to use other nicotine substitutes ( i.e., OTC or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
Uncon [...] on a case by case basis by the Study [...]
Study description+561 characters
Study Groups:
If youparticipant areis found to be eligible to take part in this study, youthey will be randomly assigned (as in the roll of a dice) to 1 o [...] y group is better, the same, or worse than the other group.
YouParticipant will have an equal chance of being assigned to Group 1 or 2.
If youparticipant areis in Group 1, youthey will receive varenicline and a placebo patch.
A placebo is [...] udy drug to learn if the study drug has any real effect.
If youparticipant areis in Group 2, youthey will receive an active nicotine patch and a placebo tablet.
Neither youparticipant nor the study doctor wi [...] [...]
2014-12-12
minor
Study Identification, Study Status v1
Primary completion date2018-12→2019-04
Start date2014-12→2015-04