Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institute on Drug Abuse (NIDA)
• Treatments: Naltrexone; Varenicline

Criteria

Inclusion Criteria:

1. Between the ages of 18 and 75

2. Smoking 10 or more cigarettes per day

3. Fewer than 3 months of smoking abstinence in the past year

4. Motivated to stop smoking

Exclusion Criteria:

1. Current use of opiates, and/or a urine toxicology screen positive for opiates

2. Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)

3. Evidence of significant hepatocellular injury as evidence by AST or ALT >3 x normal or elevated bilirubin

4. History of cirrhosis

5. Any serious or unstable disease within 6 months

6. Seizure risk

7. Diabetes mellitus requiring insulin or oral hypoglycemic medications

8. Hepatic or renal impairment

9. Use of a monoamine oxidase inhibitor in the prior 14 days

10. Clinically significant cardiovascular disease within 6 months

11. Uncontrolled hypertension

12. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg

13. Severe chronic obstructive pulmonary disease

14. History of cancer (except treated basal cell or squamous cell carcinoma of the skin)

15. History of clinically significant allergic reactions

16. Major depressive disorder within the past year requiring treatment

17. History of or current panic disorder, psychosis, bipolar disorder, or eating disorders

18. Alcohol or drug abuse/dependency within the past year

19. Use of another investigational drug within 30 days

20. Intention to donate blood or blood products during the treatment phase of the study

21. Use of tobacco products other than cigarettes or use of marijuana

22. Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment or intention to use medication that might interfere with study medication

23. Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45 kg.

24. Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral injectable, or implantable contraceptives, intrauterine device, or barrier method with spermacide)