Tobacco Use DisorderPhase 1NCT00271206
Effect of Progesterone on Smoking Behavior in Male and Female Smokers
A Phase 1 study testing Progesterone and sugar pill in people with Tobacco Use Disorder, run by Yale University at 1 site in United States.
Trial summary
Past research on nicotine addiction has shown that changes in estradiol and progesterone hormone levels during menstruation may cause women to respond differently than men to nicotine. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Progesterone and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2008
- Phase
- Phase 1
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of smoking 10-25 cigarettes daily for the past 12 months
- Score of at least 5 on the Fagerström Nicotine Tolerance Questionnaire
- Carbon monoxide level greater than 10 ppm
- Body mass index between 19 to 36
- Currently in good health, as determined by medical history, screening examination, and laboratory tests
- If female, regular menstrual cycle every 25 to 35 days
- If female, willing to use non-hormonal contraception throughout the study
Who cannot join
- Seeking treatment for nicotine dependence
- History of major medical illness, including liver disease; abnormal vaginal bleeding; suspected or known tumors; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; stroke; or other medical conditions that are considered unsafe for study participants by the investigator
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- Recent diagnosis and treatment for Axis I disorders, including major depression, bipolar affective disorder, schizophrenia, or panic disorder
- Currently abusing alcohol or other recreational or prescription drugs
- Current use of any tobacco products other than cigarettes, including smokeless tobacco and nicotine products
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- Known allergy to progesterone
- Known allergy to peanuts
- If female, amenorrhea
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Health Care System
New Haven, Connecticut, 06519
About this study
Official title: Progesterone and the Effects of Nicotine
Past research on nicotine addiction has shown that changes in estradiol and progesterone hormone levels during menstruation may cause women to respond differently than men to nicotine. The purpose of this study is to examine the effects of progesterone on smoking behavior, nicotine withdrawal symptoms, and the reinforcing effects of smoking in men and women addicted to nicotine.
Read the detailed description
Nicotine addiction is a serious health problem. Almost 35 million people in the United States try to quit smoking each year, but less than 7 percent are successful. Many smokers report a "high" sensation, followed by a feeling of relaxation. Such positive reinforcement factors, combined with nicotine cravings, make it difficult to stop the use of nicotine products. Past research has suggested that women may experience fewer nicotine cravings and may be less affected by smoking's positive reinforcement factors when compared to men. Fluctuations in levels of the female hormones estradiol and progesterone during menstruation may play a role in determining how women are affected by nicotine. The purpose of this study is to examine the effects of a controlled oral dose of progesterone on smoking behavior, nicotine withdrawal symptoms, and nicotine-related positive reinforcement factors in nicotine dependent males and females.
In this 4-day study, participants will be randomly assigned to receive a daily dose of 200 mg of progesterone, 400 mg of progesterone, or placebo. All participants will abstain from smoking for Days 1 through 3. On Day 4, participants will take part in a smoking session, during which their smoking habits, including the number of puffs, duration of puffs, and number of cigarettes smoked, will be measured. Outcome measurements will include self-reports of cravings; carbon monoxide monitoring; and standardized questionnaires to assess nicotine withdrawal symptoms.
This study has been completed with 35 men and 30 women. With the final women completing in March of 2008. This protocol is complete and has been published.
- Conditions
- Tobacco Use Disorder
- Being tested
- Progesterone, sugar pill
- Keywords
- Nicotine Dependence, Tobacco Dependence
- 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.
ProgesteroneDrug
compared to placebo
sugar pillDrug
Compared to progesterone
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Active comparator | 200 mg to 400mg of progesterone Receives: Drug: Progesterone |
| Sugar Pill | Placebo comparator | Will mirror active medication Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking topography; measured by carbon monoxide levels and self-report at Day 4
Measured: 4 years anticipated
Nicotine withdrawal symptoms; measured by the Minnesota Nicotine Withdrawal Scale at Day 4
Measured: Anticipated 4 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mehmet Sofuoglu, PhD, Principal investigator, Yale University, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271206
- Sponsor's protocol ID
- 0407026935
- Other IDs
- R01DA014537, DPMC
- Status last verified
- Mar 2020
- First submitted
- 28 Dec 2005
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone and the Effects of Nicotine
- ClinicalTrials.gov ID
- NCT00271206
- Acronym / sponsor ID
- 0407026935
- Conditions
- Tobacco Use Disorder
- Keywords
- Nicotine Dependence, Tobacco Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Dec 2005 (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.
Past research on nicotine addiction has shown that changes in estradiol and progesterone hormone levels during menstruation may cause women to respond differently than men to nicotine. The purpose of this study is to examine the effects of progesterone on smoking behavior, nicotine withdrawal symptoms, and the reinforcing effects of smoking in men and women addicted to nicotine.
Detailed description
Nicotine addiction is a serious health problem. Almost 35 million people in the United States try to quit smoking each year, but less than 7 percent are successful. Many smokers report a "high" sensation, followed by a feeling of relaxation. Such positive reinforcement factors, combined with nicotine cravings, make it difficult to stop the use of nicotine products. Past research has suggested that women may experience fewer nicotine cravings and may be less affected by smoking's positive reinforcement factors when compared to men. Fluctuations in levels of the female hormones estradiol and progesterone during menstruation may play a role in determining how women are affected by nicotine. The purpose of this study is to examine the effects of a controlled oral dose of progesterone on smoking behavior, nicotine withdrawal symptoms, and nicotine-related positive reinforcement factors in nicotine dependent males and females.
In this 4-day study, participants will be randomly assigned to receive a daily dose of 200 mg of progesterone, 400 mg of progesterone, or placebo. All participants will abstain from smoking for Days 1 through 3. On Day 4, participants will take part in a smoking session, during which their smoking habits, including the number of puffs, duration of puffs, and number of cigarettes smoked, will be measured. Outcome measurements will include self-reports of cravings; carbon monoxide monitoring; and standardized questionnaires to assess nicotine withdrawal symptoms.
This study has been completed with 35 men and 30 women. With the final women completing in March of 2008. This protocol is complete and has been published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Active comparator | Drug: Progesterone200 mg to 400mg of progesterone |
| Sugar Pill | Placebo comparator | Drug: sugar pillWill mirror active medication |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- History of smoking 10-25 cigarettes daily for the past 12 months
- Score of at least 5 on the Fagerström Nicotine Tolerance Questionnaire
- Carbon monoxide level greater than 10 ppm
- Body mass index between 19 to 36
- Currently in good health, as determined by medical history, screening examination, and laboratory tests
Key exclusion criteria (10 listed)
- Seeking treatment for nicotine dependence
- History of major medical illness, including liver disease; abnormal vaginal bleeding; suspected or known tumors; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; stroke; or other medical conditions that are considered unsafe for study participants by the investigator
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- Recent diagnosis and treatment for Axis I disorders, including major depression, bipolar affective disorder, schizophrenia, or panic disorder
- Currently abusing alcohol or other recreational or prescription drugs
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 |
|---|---|---|
| Progesteronecompared to placebo | Drug | Progesterone |
| sugar pillCompared to progesterone | Drug | Sugar Pill |
Primary outcome
Smoking topography; measured by carbon monoxide levels and self-report at Day 4
Time frame: 4 years anticipated
Nicotine withdrawal symptoms; measured by the Minnesota Nicotine Withdrawal Scale at Day 4
Time frame: Anticipated 4 year study
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 2 Apr 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.
Mehmet Sofuoglu, PhD principal investigator
Yale University, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Progesterone and sugar pill in people with Tobacco Use Disorder, run by Yale University 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 7 inclusion and 10 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 2 Apr 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Smoking topography; measured by carbon monoxide levels and self-report at Day 4 (time frame: 4 years anticipated). The study lists 2 primary outcomes in all. 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 2 Apr 2020.