N/A
Completed N=17
Varenicline and Nicotine Interactions in Humans (VA)
Source: ClinicalTrials.gov NCT00606892 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Subjective Responses to Intravenous Nicotine — 23; 38; 51; 14 millimeters — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Responses to Intravenous Nicotine |
23; 38; 51; 14; 27; 37 | <0.05 sig |
| SECONDARY Mean Reaction Time (RT) on Modified Stroop Task. |
722.3; 693.1; 660.1; 624.2; 702.3; 686.7 | <0.05 sig |
| SECONDARY Cotinine Levels |
202; 185 | <0.3 |
| SECONDARY Heart Rate |
7; 13; 16; 2; 5; 5 | <0.05 sig |
| SECONDARY Changes in Systolic and Diastolic Blood Pressure |
12; 16; 8; 7; 13; 16 | — |
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
Data sourced from ClinicalTrials.gov (NCT00606892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.