HRTNCT01210586
Tobacco Cessation in Postmenopausal Women
A study testing Part 2 in people with HRT and Non-HRT, run by University of Minnesota.
Trial summary
This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Read more about this study
- Who is it for?
- Ages 40 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HRT, Non-HRT, Continued Smoking
- What is being tested?
- Part 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-79 years old
- Clinical Menopause
- > 15 cigarettes per day for at least one year
- Experienced nicotine withdrawal based on DSM IV
Who cannot join
- Currently obtaining nicotine from other sources
- Abnormal vaginal bleeding
- unstable health
- history of stroke or embolism
- history of abnormal thyroid function
- significant skin disorders
- active psychiatric disease
About this study
Official title: Tobacco Cessation in Postmenopausal Women - Part I & Part II
This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Women were recruited into two groups according to their pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks, participants were instructed to quit smoking. They were provided with smoking cessation counseling and monitored for abstinence. Data were collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction Time Test.
Part II is identical to Part I, except it randomizes participants to use nicotine patch or not.
- Conditions
- HRT, Non-HRT, Continued Smoking, Smoking Abstinence
- Being tested
- Part 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 2Behavioural
Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Patch | Active comparator | Nicotine Patch for Smoking Cessation Receives: Behavioral: Part 2 |
| Placebo Patch | Placebo comparator | Not described Receives: Behavioral: Part 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
During short term smoking abstinence, do the beneficial effects of nicotine replacement therapy on acute symptomatology differ in women who use and do not use hormone replacement therapy?
Measured: Outcome was measured after 1 baseline week and a 2 week quit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startJan 1999
- Primary completionJan 2004
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HRTStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sharon S Allen, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210586
- Sponsor's protocol ID
- 2002NT050
- Status last verified
- Jun 2020
- First submitted
- 27 Sep 2010
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Cessation in Postmenopausal Women - Part I & Part II
- ClinicalTrials.gov ID
- NCT01210586
- Acronym / sponsor ID
- 2002NT050
- Conditions
- HRT, Non-HRT, Continued Smoking, Smoking Abstinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 1999
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Women were recruited into two groups according to their pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks, participants were instructed to quit smoking. They were provided with smoking cessation counseling and monitored for abstinence. Data were collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction Time Test.
Part II is identical to Part I, except it randomizes participants to use nicotine patch or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Patch | Active comparator | Behavioral: Part 2Nicotine Patch for Smoking Cessation |
| Placebo Patch | Placebo comparator | Behavioral: Part 2 |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40-79 years old
- Clinical Menopause
- > 15 cigarettes per day for at least one year
- Experienced nicotine withdrawal based on DSM IV
Key exclusion criteria (7 listed)
- Currently obtaining nicotine from other sources
- Abnormal vaginal bleeding
- unstable health
- history of stroke or embolism
- history of abnormal thyroid function
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 |
|---|---|---|
| Part 2Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design. | Behavioural | Nicotine Patch, Placebo Patch |
Primary outcome
During short term smoking abstinence, do the beneficial effects of nicotine replacement therapy on acute symptomatology differ in women who use and do not use hormone replacement therapy?
Time frame: Outcome was measured after 1 baseline week and a 2 week quit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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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.
Sharon S Allen, MD, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Part 2 in people with HRT and Non-HRT, run by University of Minnesota.
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 4 inclusion and 7 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 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
During short term smoking abstinence, do the beneficial effects of nicotine replacement therapy on acute symptomatology differ in women who use and do not use hormone replacement therapy? (time frame: Outcome was measured after 1 baseline week and a 2 week quit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2020.