CompletedNot Applicable

Neural Mechanisms Underlying Nicotine and Alcohol Combinations

United States12 participantsStarted 2013-07

Plain-language 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

Who can participate

Age range21 Years – 40 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Functional connectivity of reward-related brain circuit

Timeframe: 1.5 hours

Trial details

NCT IDNCT02049268

SponsorMclean Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12