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Varenicline and Nicotine Interactions in Humans (VA)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00606892
First received: January 23, 2008
Last updated: September 9, 2014
Last verified: September 2014

January 23, 2008
September 9, 2014
August 2007
November 2008   (final data collection date for primary outcome measure)
Subjective Responses to Intravenous Nicotine [ Time Frame: 30 minutes after each nicotine infusion ] [ Designated as safety issue: No ]
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.
Treatment will attenuate the subjective, physiological and cognitive responses to IV nicotine. [ Time Frame: 4 to 14 days per subject ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00606892 on ClinicalTrials.gov Archive Site
  • Mean Reaction Time (RT) on Modified Stroop Task. [ Time Frame: pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine) ] [ Designated as safety issue: No ]
    A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).
  • Cotinine Levels [ Time Frame: Before each laboratory session on day 5 ] [ Designated as safety issue: No ]
    Subject Cotinine Levels before each laboratory session.
  • Heart Rate [ Time Frame: 30 minutes after each nicotine infusion ] [ Designated as safety issue: Yes ]
    The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.
  • Changes in Systolic and Diastolic Blood Pressure [ Time Frame: 30 minutes after each nicotine infusion ] [ Designated as safety issue: Yes ]
    The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.
Varenicline will intensify subjects cognition with IV nicotine [ Time Frame: 4 to 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Varenicline and Nicotine Interactions in Humans (VA)
Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • Drug: Varenicline
    Varenicline (1 mg per day) given for 4 days prior to laboratory session
    Other Name: Chantix
  • Drug: Placebo
    Sugar Pill
    Other Names:
    • Placebo
    • Sugar Pill
  • 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.
    Other Name: IV Nicotine
  • Experimental: 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).
    Interventions:
    • Drug: Varenicline
    • Drug: Placebo
    • Drug: IV Nic
  • Experimental: 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).
    Interventions:
    • Drug: Varenicline
    • Drug: Placebo
    • Drug: IV Nic
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
November 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606892
HIC # 0702002338, MIRECC 000000000, DPMC, R01DA014537
Yes
Yale University
Yale University
  • Department of Veterans Affairs
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University Associate Professor
Yale University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP