Sensitivity to Intravenous Nicotine: Genetic Moderators

NCT00969137 | Completed Phase 1 DMC

• 3 other identifiers: 0905005103R03DA027474DCNBR / CNB
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Dependence

Keywords

smoking, nicotine, cigarettes

Outcome Measures

Primary Outcomes (1)

• primary hypotheses will test the influence of OPRM1 A118G status on subjective responses to IV nicotine, which will be measured with the drug effects questionnaire (DEQ).

  Injections 30 minutes apart

Study Arms (2)

Nicotine

ACTIVE COMPARATOR

Intravenous Nicotine

Drug: Nicotine

Saline

PLACEBO COMPARATOR

Saline infusion

Drug: saline

Interventions

saline DRUG

intravenous saline

Saline

Nicotine DRUG

Intravenous nicotine

Nicotine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Department of Veterans Affairs

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Sodium Chloride; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mehmet Sofuoglu, M.D,Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: June 2, 2009
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)