Proof-of-Concept Study of EVP-6124, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, Versus Placebo in Subjects With Nicotine Dependence
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Nicotine Dependence - Smoking Cessation |
| Purpose: |
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This study is designed to evaluate the initial evidence for efficacy of the investigational
medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper
of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Self-report of smoking an average of ≥10 cigarettes/day for 6 months and expired CO
≥10 parts per million (ppm) or urine cotinine ≥100 ng/mL at screening
- Self-report of smoking first cigarette of the day within 30 minutes of awakening
- Have a negative urine drug screen at screening
- Fertile, sexually active subjects (males and females) must use an effective method of
contraception from the first dose of study drug and for 3 months after the last dose
of study drug
- If female and capable of conception, must have a negative urine hCG pregnancy test at
screening and Day 1
Exclusion Criteria:
- Have unstable medical illness with hospitalization for treatment likely within 6
months
- Have life-threatening arrhythmia, cerebrovascular or cardiovascular event within 6
months of enrollment
- Have liver function tests elevated >2.5 times the upper limit of normal range
- Have a tumor or a seizure disorder
- Currently using other tobacco- or nicotine-containing products and unwilling to try
to quit
- Have a 6-month history of substance use disorder other than nicotine or caffeine or
major depressive disorder
- Have a history of multiple adverse drug reactions
- Non-response (past 3 months) to NRT >20 mg/day, bupropion >150 mg/day, or varenicline
2 mg/day for ≥4 weeks
- Use of excluded concomitant medications
- Hospitalization for any reason within 30 days of screening
- Use of any investigational drug or device within 30 days of screening
- Have clinically significant abnormal serum electrolytes
- Have insufficiently controlled diabetes mellitus
- Have renal insufficiency (serum creatinine >1.8 mg/dL)
- Malignant tumor within the last 5 years, with the exception of squamous and basal
cell carcinoma or cervical carcinoma in situ
- Have a clinically significant cardiovascular abnormality on the screening EKG
- Lifetime history of schizophrenia, bipolar disorder, post-traumatic stress disorder,
bulimia, organic mental disorder, dementia, pervasive developmental disorder
- Have untreated, clinically significant hypothyroidism or hyperthyroidism
- Have a positive self-report of human immunodeficiency virus infection
- Females who are pregnant or nursing
- Any experimental drug currently or within 30 days before baseline
- Have a serious risk of suicide
- Have a screening ECG with a corrected QT (QTc) interval using Bazett's formula >450
msec for males and >470 msec for females or the presence of any clinically
significant cardiac abnormalities
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| NCT ID: |
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NCT01480232 |
| Primary Contact: |
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Principal Investigator
Anne Eden Evins, MD, MPH
Massachusetts General Hospital
Vicenta B. Hudziak, BA
Phone: 617-724-8472
Email: a7smoking@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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