Overview

This trial is active, not recruiting.

Condition focus: effects of nicotine and alcohol on brain circuits
Treatments nicotine + alcohol, placebo nicotine + alcohol, nicotine + placebo alcohol
Sponsor Mclean Hospital
Start date July 2013
End date December 2015
Trial size 40 participants
Trial identifier NCT02049268, 2012P000217

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Experimental)
A nicotine patch will be applied to the subject. After a 3-4 hour uptake period, subjects will undergo a single MRI session. Baseline (nicotine only) measurements will be made, then participants will drink an alcoholic beverage. Post-alcohol measurements will be made after a 20 minute uptake period.
nicotine + alcohol Nicoderm CQ Clear
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)
(Experimental)
A placebo nicotine patch will be applied to the subject. After a 3-4 hour uptake period, subjects will undergo a single MRI session. Baseline (placebo nicotine) measurements will be made, then participants will drink an alcoholic beverage. Post-alcohol measurements will be made after a 20 minute uptake period.
placebo nicotine + alcohol Nicoderm CQ Clear
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)
(Experimental)
A nicotine patch will be applied to the subject. After a 3-4 hour uptake period, subjects will undergo a single MRI session. Baseline (nicotine only) measurements will be made, then participants will drink a placebo alcoholic beverage. Post-alcohol measurements will be made after a 20 minute uptake period.
nicotine + placebo alcohol Nicoderm CQ Clear
14 mg nicotine patch applied in combination with 400 mL orange juice beverage with a trace of alcohol to create placebo alcohol mixture.

Primary Outcomes

Measure
Functional connectivity of reward-related brain circuit
time frame: 1.5 hours
Functional connectivity of visual, motor, and sensorimotor brain circuits
time frame: 1.5 hours

Secondary Outcomes

Measure
Exploratory investigation of oxygen metabolism and perfusion underlying the functional connectivity effects
time frame: 1.5 hours

Eligibility Criteria

Male participants from 21 years up to 40 years old.

Inclusion Criteria: - Male - 21 to 40 years old - Physically healthy (normal physical exam, ECG, blood and urine chemistries) - Light/moderate cigarette smokers (greater than 10-20 cigarettes per week) - Alcohol drinkers (10 or greater drinks per week) - Must not be seeking treatment for their alcohol or tobacco use Exclusion Criteria: - Female - Diagnosis of past or current alcohol dependence as assessed by Diagnostic and Statistic Manual, DSM-IV, criteria for alcohol dependence - Diagnosis of cocaine, sedative, or opiate dependence using DSM-IV criteria - Current diagnosis of Axis I disorder using DSM-IV criteria, or any Axis I disorder within past 5 years (excluding alcohol abuse, marijuana dependence or abuse) - Current daily use of antipsychotic, antidepressant, or other psychoactive prescription drug, as well as daily use of non-prescription drugs - Life threatening or unstable medical illness, or one that can create marked change in mental state - Heavy caffeine use (greater than 400 mg on a regular, daily basis) - History of seizure disorder - Hepatitis B or C positive, or history of i.v. drug use

Additional Information

Official title Neural Mechanisms Underlying Nicotine and Alcohol Combinations
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Mclean Hospital.