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

NCT00960778 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HR#18333
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

gender; nicotine dependence; nicotine replacement therapy; extinction; denicotinized cigarettes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 7

Study Arms (4)

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.

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.

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.

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.

Drug: nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)

Interventions

nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) DRUG

Nicotine patch 21 mg every 24 hours will be utilized for the three days after the first scanning session.

Also known as: Nicoderm Committed Quitter (CQ), Habitrol, nicotine transdermal system, NRT

Men- nicotine patch; Women -nicotine patch

denicotinized cigarettes (Quest 3 cigarettes) OTHER

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.

Also known as: Quest 3 cigarettes

Men- denicotinized cigarette; Women- denicotinized cigarette

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Coitus

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Karen Hartwell
• Organization: Medical University of South Carolina

hartwelk@musc.edu

843-792-8174

Study Officials

• Karen Hartwell, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 18, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-09

Locations

US (1)