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Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate

Sponsored by Duke University

Phase Quota
Phase 2

The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.

Study Start Date: June 2013

Estimated Completion Date: February 2014

Specialties: Internal Medicine: Preventive Medicine,Women`s Health Pulmonology: Restrictive Lung Dz Family Medicine: Men`s Health,Preventive/Nutrition,Substance Abuse,Women`s Health

Interventions

  • Drug: Ganaxolone
  • Drug: Nicotine Patch

Inclusion criteria

  • Have no known serious medical conditions
  • Are 18-65 years old
  • Smoke an average of at least 10 cigarettes per day
  • Have smoked at least 1 cumulative year
  • Have an expired air CO reading of at least 10 ppm
  • Able to read and understand English
  • Express a desire to quit smoking in the next 30 days
  • Potential subjects must agree to use acceptable contraception during their participation in this study
  • Potential subjects must agree to avoid the following during their participation in this study:
    • Participation in any other nicotine-related modification strategy outside of this protocol
    • Use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco
    • Use of  experimental (investigational) drugs or devices
    • Use of illegal drugs
    • Use of opiate medications
    • Consumption of grapefruit or grapefruit juice for the first 6 weeks of study participation
    • Use of melatonin
    • Use of sedating antihistamines for the first six weeks of study participation
    • Use of alcohol during the first six weeks of study participation
    • Use of benzodiazepines

Exclusion criteria

  • Inability to attend all required experimental sessions
  • Inability to take oral drugs or adhere to medication regimens
  • Hypertension (systolic >140 mm Hg, diastolic >90 mm Hg)
  • Hypotension with symptoms (systolic
  • Coronary heart disease;
  • Lifetime history of heart attack
  • Clinically significant cardiac rhythm disorder (irregular heart rhythm)
  • Chest pains
  • Cardiac (heart) disorder
  • Extensive active skin disorder
  • Liver or kidney disorder
  • Gastrointestinal disease other than gastroesophageal reflux or heartburn
  • Active ulcers in the past 30 days
  • Currently symptomatic lung disorder/disease
  • Brain abnormality
  • Migraine headaches that occur more frequently than once per week
  • History of seizures
  • Recent, unexplained fainting spells
  • Problems giving blood samples
  • Diabetes (unless treated with diet and exercise alone)
  • Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer)
  • Other major medical condition
  • Current symptomatic psychiatric disease
  • Current depression
  • Current suicidal ideation or history of suicide attempt (in the past 5 years)
  • Pregnant or nursing mothers
  • Use (within the past 30 days) of:
    • Illegal drugs (or if the urine drug screen is positive)
    • Experimental (investigational) drugs
    • Psychiatric medications including antidepressants, antipsychotics or any other medications that are known to affect smoking cessation (eg, clonidine)
    • Corticosteroids
    • CYP 3A4 inhibitors and inducers
    • Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes
    • Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid
  • Use (within the past 14 days) of:
    • Dehydroepiandrosterone (DHEA), Pregnenolone or ganaxolone
    • Opiate medications for pain or sleep
    • Benzodiazepines or other drugs with significant sedating or anticholinergic activity
    • Use of more than one cigar a month
    • Regular alcohol use
    • Significant adverse reaction to nicotine patches in the past
    • Significant past adverse reaction to ganaxolone in the past
    • Current participation or recent participation (in the past 30 days) in another smoking study at our center or another research facility
    • Current participation in another research study

Study Locations And Contact Information

  • Duke Center for Smoking Cessation, Charlotte North Carolina
  • Duke Center for Smoking Cessation, Winston-Salem North Carolina
  • Duke Center for Smoking Cessation, Durham North Carolina
  • Duke Center for Smoking Cessation, Raleigh North Carolina

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