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Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes (BIRCWH)

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)
denicotinized cigarettes (Quest 3 cigarettes)
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring gender, nicotine dependence, nicotine replacement therapy, extinction, denicotinized cigarettes

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 21 - 60.
  2. Meet criteria for primary nicotine dependence, smoke at least 70% of days in the last 30 days prior to assessment.
  3. Participants will have afternoon end-expired carbon monoxide levels of at least 15 p.p.m. to confirm smoke inhalation.
  4. Moderate to high levels of nicotine dependence confirmed by Fagerstrom Test of Nicotine Dependence score.
  5. General good health confirmed by history & physical, serum chemistries, complete blood count, urinalysis, and electrocardiogram.
  6. Able to read and understand questionnaires and informed consent.
  7. Right-handed.
  8. Treatment seeking.
  9. Demonstrate subjective response to cues in a laboratory cue reactivity session.
  10. Able to maintain abstinence from nicotine during the study period.
  11. Participants must have a negative rapid-screening Urine Drug Screen (UDS) and pregnancy test prior to both imaging sessions and placement of the patch.
  12. Female participants will use a reliable method of birth control throughout the study.

Exclusion Criteria:

  1. Currently meets Diagnostic and Statistical Manual (DSM)-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
  2. Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
  3. Use of other tobacco products.
  4. Current use of nicotine replacement therapy or other smoking cessation treatment.
  5. 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.
  6. Current suicidal ideation with plan or homicidal ideation.
  7. Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
  8. Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit ability to participate in scan.
  9. 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.
  10. Has current charges pending for a violent crime (not including Drive Under Influence (DUI) related offenses).
  11. Persons with ferrous metal implants or pacemaker since fMRI will be used.
  12. Persons who live with another smoker who is unwilling or unable to refrain from smoking in the home or presence of the participant.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Women- denicotinized cigarette

Men- denicotinized cigarette

Women -nicotine patch

Men- nicotine patch

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2009
Last Updated
September 27, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00960778
Brief Title
Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes
Acronym
BIRCWH
Official Title
Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
gender, nicotine dependence, nicotine replacement therapy, extinction, denicotinized cigarettes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Women- denicotinized cigarette
Arm Type
Experimental
Arm Description
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.
Arm Title
Men- denicotinized cigarette
Arm Type
Experimental
Arm Description
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.
Arm Title
Women -nicotine patch
Arm Type
Experimental
Arm Description
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.
Arm Title
Men- nicotine patch
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)
Other Intervention Name(s)
Nicoderm Committed Quitter (CQ), Habitrol, nicotine transdermal system, NRT
Intervention Description
Nicotine patch 21 mg every 24 hours will be utilized for the three days after the first scanning session.
Intervention Type
Other
Intervention Name(s)
denicotinized cigarettes (Quest 3 cigarettes)
Other Intervention Name(s)
Quest 3 cigarettes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post- Cue Exposure Craving Nicotine Patch
Description
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.
Time Frame
Day 3
Title
Post- Cue Exposure Craving Denicotinized Cigarettes
Description
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.
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Hartwell, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes

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