Sensitivity to Intravenous Nicotine: Genetic Moderators

Description

To determine if the mu opioid receptor gene (OPRM1) A118G polymorphism moderates the subjective-rewarding effects of intravenous (IV) nicotine in male and female smokers. The subjective effects of nicotine will be measured with a Drug Effects Questionnaire, including the ratings of "good effects" and "drug liking". We hypothesize that smokers with the AG/GG genotype for the OPRM1 A118G will have attenuated subjective-rewarding effects from IV nicotine when compared to those with AA genotype.

Study Start Date

June 2009

Estimated Completion Date

December 2016

Interventions

  • Drug: saline
  • Drug: Nicotine

Specialties

  • Psychiatry : Mood Disorders,Neuro/Psych Pharmacol,Substance Abuse
  • Family Medicine: Substance Abuse
  • Pharmacy: Neuro/Psych pharmacology
  • Nurse Practitioner: Substance Abuse

MeSH Terms

  • Nicotine
  • Substance Abuse Disorder

Study ID

Yale University -- 0905005103

Status

Unknown

Trial ID

NCT00969137

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

300

Sponsor

Yale University

Inclusion Criteria

  • Female and male smokers, aged 18 to 50 years
  • History of smoking daily for the past 12 months, 10-25 cigarettes daily
  • Not seeking treatment at the time of the study for nicotine dependence
  • Have a FTND score of at least 5 and CO level > 10ppm
  • In good health as verified by medical history, screening examination, and screening laboratory tests
  • For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria

  • History of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study
  • Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder
  • Abuse of alcohol or any other recreational or prescription drugs.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Department of Veterans Affairs - West Haven, Connecticut 15.6 miles None None None

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