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

Completed · Phase 2

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT01857531

Run by

Jed E. Rose

People needed

36

Starts

2013-06-01

Expected to finish

2014-02-01

Last updated by the study team

2014-09-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 one cumulative year;
• Have an expired air CO reading of at least 10ppm;
• Able to read and understand English;
• Express a desire to quit smoking in the next thirty 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 six 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

You may not qualify if…

• 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 <90 mm Hg, diastolic <60 mm Hg).
• 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);

Where it is running

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

Full record on ClinicalTrials.gov

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