Varenicline and Nicotine Interactions in Humans (VA)

NCT00606892 | Completed Results DMC

• 4 other identifiers: HIC # 0702002338MIRECC 000000000DPMCR01DA014537
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

therapeutic effects

Outcome Measures

Primary Outcomes (1)

• Subjective Responses to Intravenous Nicotine

  The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from "not at all" (a score of 0) to "extremely" with a maximum score of 100.

  30 minutes after each nicotine infusion

Secondary Outcomes (4)

• Mean Reaction Time (RT) on Modified Stroop Task.

  pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)

• Cotinine Levels

  Before each laboratory session on day 5

• Heart Rate

  30 minutes after each nicotine infusion

• Changes in Systolic and Diastolic Blood Pressure

  30 minutes after each nicotine infusion

Study Arms (2)

Placebo First, varenicline, + IV Nic

EXPERIMENTAL

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).

Drug: Varenicline; Drug: Placebo; Drug: IV Nic

Varenicline first, placebo, + IV Nic

EXPERIMENTAL

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).

Drug: Varenicline; Drug: Placebo; Drug: IV Nic

Interventions

Varenicline DRUG

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

Also known as: Chantix

Placebo First, varenicline, + IV Nic; Varenicline first, placebo, + IV Nic

Placebo DRUG

Sugar Pill

Also known as: Sugar Pill

Placebo First, varenicline, + IV Nic; Varenicline first, placebo, + IV Nic

IV Nic 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.

Also known as: IV Nicotine

Placebo First, varenicline, + IV Nic; Varenicline first, placebo, + IV Nic

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• US Department of Veterans Affairs: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

• 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.

  PMID: 19693492 RESULT

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline; Sugars; Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Carbohydrates; Solanaceous Alkaloids; Alkaloids; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Mehmet Sofuoglu, M.D., Ph.D.
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203-937-4809

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 5, 2008
• Study Start: August 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2009
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (1)