Tobacco CessationNCT01744574

Sex Differences, Hormones & Smoking Cessation

A study testing Progesterone and Smoking Cessation Behavioral Counseling in people with Tobacco Cessation, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Tobacco Cessation
What is being tested?: Progesterone and Smoking Cessation Behavioral Counseling
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 216 participants
Where: 1 siteUnited States
Study dates: Dec 2012to 27 Jul 2017
Phase: Interventional
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male 18 to 60 years old
Female 18 to 50 years old
Self-report regular smoking
Motivated to quit smoking
In stable physical/mental health
Self report of regular menstrual cycles (female only)

Show all 9Show fewer

English fluency
Understand the study procedures and able to provide informed consent
Ability to participate fully in research elements for the duration of the trial.

Who cannot join

Current or recent (< 3 months) breastfeeding (females only)
Current or planned pregnancy within the next three months (females only)
Conditions contraindicated to progesterone treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Delaware Clinical Research Unit, University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation

Read the detailed description

Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or placebo (PBO).

Telephone screening and visit invitation leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion, then randomization and medication induction, stable medication with medication reduction and final evaluation for secondary outcomes.

Conditions: Tobacco Cessation
Being tested: Placebo, Progesterone, Smoking Cessation Behavioral Counseling
Medical subject headings: Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboOther
Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
ProgesteroneDrug
Also called Prometrium
The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
Smoking Cessation Behavioral CounselingOther
Subjects will receive weekly smoking cessation behavioral counseling.

Study groups in NCT01744574
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo - subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. Receives: Other: Placebo; Other: Smoking Cessation Behavioral Counseling
Progesterone	Experimental	The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. Receives: Drug: Progesterone; Other: Smoking Cessation Behavioral Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4
7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4
Measured: Week 4

Secondary outcomes (6)

Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12
7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to weeks 8 and 12
Measured: Weeks 8 and 12
Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12
Prolonged abstinence defined as having less than seven consecutive slips without a 24-hour period between any two slips prior to weeks 4, 8 and 12
Measured: Weeks 4, 8 and 12
Number of Participants With Continuous Abstinence From Smoking at Week 12
continuous abstinence defined as having no slips at all prior to week 12
Measured: Week 12
Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12
urine cotinine <50 ng/mL at weeks 4, 8 and 12
Measured: Weeks 4, 8 and 12
Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12
breath carbon monoxide ≤5 ppm at weeks 4, 8 and 12
Measured: Weeks 4, 8 and 12
Average Number of Days to Relapse
Days to relapse defined as the number of days from quit date to the first day with a slip
Measured: Days 1 through 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201227 Jul 2017

First posted6 Dec 2012 (estimated)
Study startDec 2012
Primary completion27 Jul 2017
Study completion27 Jul 2017

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.
Other trials for Tobacco CessationStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01744574
Sponsor's protocol ID: 2012NTLS074
Other IDs: P50DA033942-01
Status last verified: Jul 2019
First submitted: 13 Nov 2012
Last updated: 12 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Recruiting
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
Tobacco Use, Tobacco Use Cessation
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Recruiting
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Nicotine Use, Tobacco Use
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use

All Tobacco Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation
ClinicalTrials.gov ID: NCT01744574
Acronym / sponsor ID: 2012NTLS074
Conditions: Tobacco Cessation
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Dec 2012
Primary completion: 27 Jul 2017 (actual)
Study completion: 27 Jul 2017 (actual)
First posted: 6 Dec 2012 (estimated)
Results: Posted 28 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or placebo (PBO).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo, Other: Smoking Cessation Behavioral CounselingPlacebo - subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
Progesterone	Experimental	Drug: Progesterone, Other: Smoking Cessation Behavioral CounselingThe progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male 18 to 60 years old
Female 18 to 50 years old
Self-report regular smoking
Motivated to quit smoking
In stable physical/mental health

Key exclusion criteria (3 listed)

Current or recent (< 3 months) breastfeeding (females only)
Current or planned pregnancy within the next three months (females only)
Conditions contraindicated to progesterone treatment.

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
PlaceboPlacebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.	Other	Placebo
ProgesteroneAlso: PrometriumThe progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.	Drug	Progesterone
Smoking Cessation Behavioral CounselingSubjects will receive weekly smoking cessation behavioral counseling.	Other	Placebo, Progesterone

Primary outcome

Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4
Time frame: Week 4
7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4

6 secondary outcomes

Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12
Time frame: Weeks 8 and 12
Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12
Time frame: Weeks 4, 8 and 12
Number of Participants With Continuous Abstinence From Smoking at Week 12
Time frame: Week 12
Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12
Time frame: Weeks 4, 8 and 12
Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12
Time frame: Weeks 4, 8 and 12
Average Number of Days to Relapse
Time frame: Days 1 through 84

Results and safety

Results posted to the registry on 28 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo-Males	57	33
Progesterone-Males	56	31
Placebo-Females	52	32
Progesterone-Females	51	40

Primary outcome: Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4

Time frame: Week 4. Count of participants. Unit: Participants

Measure	Placebo-Males n = 57	Progesterone-Males n = 56	Placebo-Females n = 52	Progesterone-Females n = 51
Value	12	13	9	18

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected between enrollment and study completion (or study dropout) which ever came first; an average of 16 weeks .. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo-Males	0 of 57 (0%)	0 of 57 (0%)	0 of 57
Progesterone-Males	1 of 56 (1.8%)	0 of 56 (0%)	0 of 56
Placebo-Females	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Progesterone-Females	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Limitations and caveats (from the sponsor): Generalizability is limited as our sample included only premenopausal women. The sample size was too small to directly compare sex differences between men and women. Participants were only followed for 12 weeks.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Tobacco Cessation

Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Recruiting
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
Tobacco Use, Tobacco Use Cessation
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Recruiting
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Nicotine Use, Tobacco Use
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use

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.

Sharon S. Allen, M.D. principal investigator

Masonic Cancer Center, 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 study testing Progesterone and Smoking Cessation Behavioral Counseling in people with Tobacco Cessation, 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 9 inclusion and 3 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 12 Jul 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2018). 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?

Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4 (time frame: Week 4). 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 NCT01744574.

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 12 Jul 2019.