Functional Magnetic Resonance Imaging (fMRI) Investigation of Nicotine Withdrawal Symptoms

NCT00657020 | Completed Phase 4 Results

• 1 other identifier: S3250493
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single center, double blind, randomized, placebo controlled, two-treatments, two-period crossover study conducted in adult smokers.

Conditions

Smoking

Keywords

nicotine; therapy; fMRI/EEG; replacement

Outcome Measures

Primary Outcomes (1)

• Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Rapid Visual Information Processing (RVIP) Task

  In RVIP task, participant responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participant responded to single occurrences of the number "0". BOLD fMRI signals evaluated different brain regions of interest (ROI) during RVIP task. Brain ROIs identified were right and left anterior insula, anterior putamen, parietal cortex, premotor cortex, visual cortex, dorsal anterior cingulate cortex, substantia nigra and thalamus.

  Approximately 2 hours post dose administration

Secondary Outcomes (5)

• Mean Response Time for Correct Responses During RVIP Task

  Approximately 2 hours post dose administration

• Mean Percentage of Correct Responses During RVIP Task

  Approximately 2 hours post dose administration

• Percent Mean Change in BOLD Scores During Divided Attention (DIA) Task

  Approximately 2 hours post dose admininstration

• Mean Response Time for Correct Responses During DIA Task

  Approximately 2 hours post dose administration

• Mean Percentage of Correct Responses During DIA Task

  Approximately 2 hours post dose administration

Study Arms (2)

Nicotine lozenge

EXPERIMENTAL

Nicotine lozenge containing 4 mg of nicotine to be placed in mouth and suck to dissolution.

Drug: Nicotine

Placebo lozenge

PLACEBO COMPARATOR

Placebo lozenge to be placed in mouth and suck to dissolution.

Drug: Placebo

Interventions

Nicotine DRUG

Nicotine lozenge containing 4 mg of nicotine

Nicotine lozenge

Placebo DRUG

Placebo lozenge

Placebo lozenge

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Weight and size
• Body mass index (BMI) within the range 19.0-32.0 kg/m.
• Able to fit comfortably within the MR scanner.
• Smoking Status
• Cigarette smokers that consume their first manufactured cigarette (i.e., not self rolled cigarettes) within 30 min of waking.
• Individuals who have smoked regularly for at least a year.
• Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Good general health with (in the opinion of the examining study doctor) no clinically significant and relevant abnormalities of medical history, physical examination or clinical laboratory test.
• Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

You may not qualify if:

• Women who are pregnant or who have a positive urine pregnancy test or
• who are breast-feeding.
• Disease/Illness
• Any clinically significant medical history or abnormality found on physical examination, laboratory assessment or electrocardiogram (ECG) at screening which, in the opinion of the investigator, could interfere with the interpretation of efficacy or safety data or which otherwise would contraindicate participation in a clinical trial.
• Current or recent history or presence of a neurological diagnosis (not limited to but including for example, stroke, traumatic brain injury, carotid arterial sclerotic disease, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, major depression etc.) that may influence the outcome or analysis of the scan results.
• Contraindications to MR scanning
• Intracranial aneurysm clips
• History of intra-orbital metal fragments that have not been removed by a doctor (as confirmed by orbital X-Ray).
• Inner ear implants.
• Tattoos with metal containing inks or piercings that can not be removed except those, which, in the opinion of the Investigator, will not interfere with the study procedures or compromise safety.
• History of claustrophobia or subject feels unable to lie still on their back for a period of 90 min in the MR scanner.
• Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire supported by plain X-Rays where appropriate.
• Prior/Concomitant Medication
• Use of any central nervous system (CNS) active, prescription medication within 14 days of first treatment visit.
• Use of any over the counter (OTC) medication within 14 days of each treatment visit except those, which, in the opinion of the Investigator, will not interfere with the study procedures or compromise safety. Paracetamol (up to 2 g) may be taken up to 24 hrs prior to each treatment visit.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Smoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 14, 2008
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 2, 2015
• Results First Posted: April 6, 2010

Record last verified: 2013-06