Status:
COMPLETED
Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate
Lead Sponsor:
Jed E. Rose
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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)...
Detailed Description
The purpose of this proof-of-concept study is to evaluate whether expired air carbon monoxide (CO) will be reduced and smoking cessation success rates enhanced for smokers who receive the neurosteroid...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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);
- 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 (e.g. clonidine);
- Corticosteroids;
- Cytochrome P450 341 (CYP3A4) 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01857531
Start Date
June 1 2013
End Date
February 1 2014
Last Update
September 8 2014
Active Locations (4)
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1
Duke Center for Smoking Cessation
Charlotte, North Carolina, United States, 28210
2
Duke Center for Smoking Cessation
Durham, North Carolina, United States, 27705
3
Duke Center for Smoking Cessation
Raleigh, North Carolina, United States, 27609
4
Duke Center for Smoking Cessation
Winston-Salem, North Carolina, United States, 27103