Varenicline and Nicotine Interactions in Humans (VA)

NCT ID: NCT00606892

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-11-30

Brief Summary

To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.

Detailed Description

This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo First, varenicline, + IV Nic

Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg).

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Varenicline (1 mg per day) given for 4 days prior to laboratory session

Placebo

Intervention Type: DRUG

Sugar Pill

IV Nic

Intervention Type: DRUG

IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.

Varenicline first, placebo, + IV Nic

Subjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg).

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Varenicline (1 mg per day) given for 4 days prior to laboratory session

Placebo

Intervention Type: DRUG

Sugar Pill

IV Nic

Intervention Type: DRUG

IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.

Interventions

Varenicline

Varenicline (1 mg per day) given for 4 days prior to laboratory session

Intervention Type: DRUG

Placebo

Sugar Pill

Intervention Type: DRUG

IV Nic

IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.

Intervention Type: DRUG

Other Intervention Names

Chantix; Sugar Pill; IV Nicotine

Eligibility Criteria

Inclusion Criteria

• Female and male smokers, aged 18 to 55 years
• History of smoking daily for the past 12 months, at least 15 cigarettes daily
• Carbon Monoxide (Alveolar) level > 10ppm
• For women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods

Exclusion Criteria

• History of heart disease, renal or hepatic diseases
• other medical conditions that the physician investigator deems as contraindicated for the subject to be in the study
• Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
• recent psychiatric diagnosis and treatment for Axis I disorders including
• major depression, bipolar affective disorder,
• schizophrenia and panic disorder within the past year
• Current dependence on alcohol
• drugs or treatments for drug
• alcohol addiction within the past 5 years
• Allergy to varenicline

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehmet Sofuoglu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University Associate Professor

Locations

Veterans Affairs Hospital

West Haven, Connecticut, United States

Countries

United States

References

Sofuoglu M, Herman AI, Mooney M, Waters AJ. Varenicline attenuates some of the subjective and physiological effects of intravenous nicotine in humans. Psychopharmacology (Berl). 2009 Nov;207(1):153-62. doi: 10.1007/s00213-009-1643-z. Epub 2009 Aug 20.

Reference Type: RESULT

PMID: 19693492 (View on PubMed)

Other Identifiers

MIRECC 000000000

Identifier Type: REGISTRY

Identifier Source: secondary_id

DPMC

Identifier Type: OTHER

Identifier Source: secondary_id

R01DA014537

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HIC # 0702002338

Identifier Type: -

Identifier Source: org_study_id