Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00960778 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
33
Enrollment target

NCT00960778: Completed Phase 2 study, sponsored by Medical University of South Carolina.

NCT00960778 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00960778, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
33 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)
  • OTHER denicotinized cigarettes (Quest 3 cigarettes)

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2009-03
Est. Completion 2012-06
Phase Phase 2

What the finished NCT00960778 record still lists

NCT00960778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 2 interventions - of which nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) is the first listed.

NCT00960778 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00960778 about?

NCT00960778 is a clinical study titled "Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes". 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 ...

What is the current status of trial NCT00960778?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2009-03. Estimated completion is 2012-06.

What interventions are being tested in trial NCT00960778?

The interventions under investigation include: nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) (DRUG), denicotinized cigarettes (Quest 3 cigarettes) (OTHER).

Who is sponsoring clinical trial NCT00960778?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00960778's enrollment target sits among peer trials

33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02861898 · 33 participants · Phase 1

    Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

  • NCT04871607 · 33 participants · Phase 2

    Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma

  • NCT05071937 · 33 participants · Phase 2

    ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer

  • NCT05168618 · 33 participants · Phase 2

    Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer, The AtezoCab Trial

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00960778, the US trial registry maintained by the National Library of Medicine. NCT00960778 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.