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Neural Mechanisms Underlying Nicotine and Alcohol Combinations

NCT02049268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-02-03

No results posted yet for this study

Summary

Nicotine and alcohol are frequently used together and their combined use contributes to more than half a million deaths each year, with more alcoholics dying from smoking-related diseases than from alcohol-related diseases. Using a new multi-modal MRI approach combined with data fusion, the investigators propose to study how nicotine modulates alcohol-induced changes in the function of brain circuits. The investigators hypotheses are:

* functional connectivity (FC) in the reward network, containing components of the mesolimbic dopamine system, will be altered by alcohol, and additional increases in FC will be observed if nicotine is also present (e.g., additive effects).
* co-administration of nicotine will counteract the effects of alcohol on FC in multiple brain networks, including visual, sensorimotor and motor brain circuits, that may be associated with the impairing effects of alcohol

Conditions

  • Focus: Effects of Nicotine and Alcohol on Brain Circuits

Interventions

DRUG

Nicotine + Alcohol

14 mg nicotine patch applied in combination with vodka and orange juice alcoholic beverage (to reach blood alcohol level (BAL) = 0.08 based on subject weight, which is approximately 2-3 drinks for 400 mL volume)

DRUG

Placebo Nicotine + Alcohol

Placebo nicotine patch applied in combination with vodka and orange juice alcoholic beverage (to reach BAL = 0.08 based on subject weight, which is approximately 2-3 drinks for 400 mL volume)

DRUG

Nicotine + Placebo Alcohol

14 mg nicotine patch applied in combination with 400 mL orange juice beverage with a trace of alcohol to create placebo alcohol mixture.

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Lisa D Nickerson, PhD · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02049268 on ClinicalTrials.gov