Nicotine DependencePhase 2BIRCWHNCT00960778
Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes
A Phase 2 study testing nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) and denicotinized cigarettes (Quest 3 cigarettes) in people with Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will investigate the underlying neurobiology of differences between male and female smokers. Research suggests that women are less responsive to nicotine replacement therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) and denicotinized cigarettes (Quest 3 cigarettes)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2012
- Phase
- Phase 2
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21 - 60.
- Meet criteria for primary nicotine dependence, smoke at least 70% of days in the last 30 days prior to assessment.
- Participants will have afternoon end-expired carbon monoxide levels of at least 15 p.p.m. to confirm smoke inhalation.
- Moderate to high levels of nicotine dependence confirmed by Fagerstrom Test of Nicotine Dependence score.
- General good health confirmed by history \& physical, serum chemistries, complete blood count, urinalysis, and electrocardiogram.
- Able to read and understand questionnaires and informed consent.
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- Right-handed.
- Treatment seeking.
- Demonstrate subjective response to cues in a laboratory cue reactivity session.
- Able to maintain abstinence from nicotine during the study period.
- Participants must have a negative rapid-screening Urine Drug Screen (UDS) and pregnancy test prior to both imaging sessions and placement of the patch.
- Female participants will use a reliable method of birth control throughout the study.
Who cannot join
- Currently meets Diagnostic and Statistical Manual (DSM)-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
- Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
- Use of other tobacco products.
- Current use of nicotine replacement therapy or other smoking cessation treatment.
- Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. The rationale for excluding them is that symptoms from these disorders may affect dependent variables and complicate interpretation of the data.
- Current suicidal ideation with plan or homicidal ideation.
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- Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
- Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit ability to participate in scan.
- Sexually active females of child-bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
- Has current charges pending for a violent crime (not including Drive Under Influence (DUI) related offenses).
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
- Persons who live with another smoker who is unwilling or unable to refrain from smoking in the home or presence of the participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
This study will investigate the underlying neurobiology of differences between male and female smokers. Research suggests that women are less responsive to nicotine replacement therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking. This study proposed that male smokers will have a greater response to NRT demonstrated by reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues as compared to female smokers treated with NRT. Additionally, female smokers will have a greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.
Read the detailed description
Women smokers are less responsive to nicotine replacement therapy (NRT) and more responsive to environmental cues associated with smoking behavior. This pilot study is designed to increase understanding of the neural circuitry underlying these differences. In the proposed study, adult male and female (10 per group) treatment-seeking nicotine-dependent individuals will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues under three conditions during a seven day period: baseline, after NRT, and after denicotinized cigarette facilitated-extinction. After baseline scanning, subjects will receive three days of 21 mg nicotine patch. Scanning procedures will be repeated on day 3. Subjects will then receive denicotinized cigarettes for ad lib smoking on days three through seven. Subjects will be asked to remain abstinent throughout the study period and they will be assessed daily with self-report, Carbon Monoxide (CO) monitor and for nicotine withdrawal.
- Conditions
- Nicotine Dependence
- Being tested
- nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol), denicotinized cigarettes (Quest 3 cigarettes)
- Keywords
- gender, nicotine dependence, nicotine replacement therapy, extinction, denicotinized cigarettes
- Medical subject headings
- Tobacco Use Disorder, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)Drug
Also called Nicoderm Committed Quitter (CQ), Habitrol, nicotine transdermal system, NRT
Nicotine patch 21 mg every 24 hours will be utilized for the three days after the first scanning session.
denicotinized cigarettes (Quest 3 cigarettes)Other
Also called Quest 3 cigarettes
Cigarettes that contain trace levels of nicotine (less than .05 mg per cigarette) will be utilized ad lib in the study for 4 days after the nicotine patch.
| Study group | Role | What they receive |
|---|---|---|
| Women- denicotinized cigarette | Experimental | Treatment-seeking nicotine-dependent women will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues after four days of denicotinized cigarette (less than 0.5 gram nicotine) use. Receives: Other: denicotinized cigarettes (Quest 3 cigarettes) |
| Men- denicotinized cigarette | Experimental | Treatment-seeking nicotine-dependent men will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues after four days of denicotinized cigarette (less than 0.5 gram nicotine) use. Receives: Other: denicotinized cigarettes (Quest 3 cigarettes) |
| Women -nicotine patch | Experimental | Treatment-seeking nicotine-dependent women will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues under after receiving three days of a 21 mg nicotine patch. Receives: Drug: nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) |
| Men- nicotine patch | Experimental | Treatment-seeking nicotine-dependent men will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues under after receiving three days of a 21 mg nicotine patch. Receives: Drug: nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post- Cue Exposure Craving Nicotine Patch
Participants will complete cue exposure sessions after 3 days of nicotine patch use and rate craving on a 10 item self-report questionnaire. The Within Sessions Rating scale measures craving with 0 indicating Not at All and 10 indicating Extremely.
Measured: Day 3
Post- Cue Exposure Craving Denicotinized Cigarettes
Participants will complete cue exposure sessions after 4 days of denicotinized cigarette us and rate craving on a 10 item self-report questionnaire, the Questionnaire of Smoking Urges- Brief (QSU-B). Participants rate craving on a scale on a 1-7 point Likert scale where indicates Strongly Disagree and 7 indicates Strongly Agree. Higher scores indicate higher craving. Ratings from the 10 items are summed to attain the score reported here.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2012
- Study completionJun 2012
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 Nicotine DependenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Hartwell, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960778
- Sponsor's protocol ID
- HR#18333
- Acronym
- BIRCWH
- Status last verified
- Sep 2018
- First submitted
- 14 Aug 2009
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes
- ClinicalTrials.gov ID
- NCT00960778
- Acronym / sponsor ID
- BIRCWH / HR#18333
- Conditions
- Nicotine Dependence
- Keywords
- gender, nicotine dependence, nicotine replacement therapy, extinction, denicotinized cigarettes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the underlying neurobiology of differences between male and female smokers. Research suggests that women are less responsive to nicotine replacement therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking. This study proposed that male smokers will have a greater response to NRT demonstrated by reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues as compared to female smokers treated with NRT. Additionally, female smokers will have a greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.
Detailed description
Women smokers are less responsive to nicotine replacement therapy (NRT) and more responsive to environmental cues associated with smoking behavior. This pilot study is designed to increase understanding of the neural circuitry underlying these differences. In the proposed study, adult male and female (10 per group) treatment-seeking nicotine-dependent individuals will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues under three conditions during a seven day period: baseline, after NRT, and after denicotinized cigarette facilitated-extinction. After baseline scanning, subjects will receive three days of 21 mg nicotine patch. Scanning procedures will be repeated on day 3. Subjects will then receive denicotinized cigarettes for ad lib smoking on days three through seven. Subjects will be asked to remain abstinent throughout the study period and they will be assessed daily with self-report, Carbon Monoxide (CO) monitor and for nicotine withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Women- denicotinized cigarette | Experimental | Other: denicotinized cigarettes (Quest 3 cigarettes)Treatment-seeking nicotine-dependent women will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues after four days of denicotinized cigarette (less than 0.5 gram nicotine) use. |
| Men- denicotinized cigarette | Experimental | Other: denicotinized cigarettes (Quest 3 cigarettes)Treatment-seeking nicotine-dependent men will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues after four days of denicotinized cigarette (less than 0.5 gram nicotine) use. |
| Women -nicotine patch | Experimental | Drug: nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)Treatment-seeking nicotine-dependent women will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues under after receiving three days of a 21 mg nicotine patch. |
| Men- nicotine patch | Experimental | Drug: nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)Treatment-seeking nicotine-dependent men will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues under after receiving three days of a 21 mg nicotine patch. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age 21 - 60.
- Meet criteria for primary nicotine dependence, smoke at least 70% of days in the last 30 days prior to assessment.
- Participants will have afternoon end-expired carbon monoxide levels of at least 15 p.p.m. to confirm smoke inhalation.
- Moderate to high levels of nicotine dependence confirmed by Fagerstrom Test of Nicotine Dependence score.
- General good health confirmed by history \& physical, serum chemistries, complete blood count, urinalysis, and electrocardiogram.
Key exclusion criteria (12 listed)
- Currently meets Diagnostic and Statistical Manual (DSM)-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
- Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
- Use of other tobacco products.
- Current use of nicotine replacement therapy or other smoking cessation treatment.
- Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. The rationale for excluding them is that symptoms from these disorders may affect dependent variables and complicate interpretation of the data.
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 (Nicoderm Committed Quitter (CQ), Habitrol)Also: Nicoderm Committed Quitter (CQ), Habitrol, nicotine transdermal system, NRTNicotine patch 21 mg every 24 hours will be utilized for the three days after the first scanning session. | Drug | Men- nicotine patch, Women -nicotine patch |
| denicotinized cigarettes (Quest 3 cigarettes)Also: Quest 3 cigarettesCigarettes that contain trace levels of nicotine (less than .05 mg per cigarette) will be utilized ad lib in the study for 4 days after the nicotine patch. | Other | Men- denicotinized cigarette, Women- denicotinized cigarette |
Primary outcome
Post- Cue Exposure Craving Nicotine Patch
Time frame: Day 3
Participants will complete cue exposure sessions after 3 days of nicotine patch use and rate craving on a 10 item self-report questionnaire. The Within Sessions Rating scale measures craving with 0 indicating Not at All and 10 indicating Extremely.
Post- Cue Exposure Craving Denicotinized Cigarettes
Time frame: Day 7
Participants will complete cue exposure sessions after 4 days of denicotinized cigarette us and rate craving on a 10 item self-report questionnaire, the Questionnaire of Smoking Urges- Brief (QSU-B). Participants rate craving on a scale on a 1-7 point Likert scale where indicates Strongly Disagree and 7 indicates Strongly Agree. Higher scores indicate higher craving. Ratings from the 10 items are summed to attain the score reported here.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karen Hartwell, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) and denicotinized cigarettes (Quest 3 cigarettes) in people with Nicotine Dependence, run by Medical University of South Carolina 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 12 inclusion and 12 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 23 Oct 2018. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Oct 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?
Post- Cue Exposure Craving Nicotine Patch (time frame: Day 3). 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 23 Oct 2018.