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Psychotropic Drugs Effects | Imaging the Effects of Zolpidem and Alprazolam in Healthy Volunteers at 3T

Psychotropic Drugs Effects research study

What is the primary objective of this study?

The primary goal of this double-blind, placebo-controlled, within-subjects functional neuroimaging study is to examine the extent to which the hypnotic zolpidem decreases brain activity in regions of the brain known to process emotional information. Although zolpidem is an effective sleep-aid, its ability to engender anti-anxiety effects is equivocal, yet promising. Zolpidem's activity during tasks that engage anxiety-related processes in the brain will be compared to that of the known anxiolytic drug alprazolam, a positive comparator caffeine, and placebo. A secondary goal of this study is to compare the subjective drug effects, or how individuals feel, following the interventions. These measures will be used to determine the existence of brain-behavior relationships, thus demonstrating that imaging is an important tool for informing us about how drugs produce their effects in the brain.

Who is eligible to participate?

- Participants will be right-handed male and female volunteers between the ages of 21-40 - Participants will consume between 100 and 300 mg caffeine on a daily basis - Participants cannot meet DSM-IV criteria for lifetime and/or current mood, anxiety, psychotic, and alcohol/drug use disorders as identified by the SCID - Participants must report ≤ 10 lifetime experiences with substances other than nicotine and alcohol - Participants cannot be taking any prescription medication (except certain short-term anti fungal agents and some topical creams for dermal conditions) - Participants cannot be taking any psychotropic medications - Non-smoking participants are preferred, but will admit those who smoke less than 5 cigarettes per day - Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders. - Participants cannot have any conditions that are contraindicated for MRI - Participants cannot have a family history of alcoholism - Participants cannot have any abnormal blood chemistries/urinalysis results, current or past cardiac problems, or any other medical condition that may affect drug disposition (e.g., Hepatitis C) - Participants cannot be taking oral contraceptives (Kalow and Tank, 1991; O'Connell, 1995) or be pregnant - Participants must be able to read screening materials including consent form and give informed consent

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Psychotropic Drugs Effects

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Zolpidem

Drug:Alprazolam

Drug:Caffeine

Other:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Zolpidem, Alprazolam, Caffeine, and PlaceboThe 4 medications are given in a counterbalanced design.

Study Status

Unknown status

Start Date: July 2011

Completed Date: December 2013

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: Change in blood oxygen level-dependent (BOLD) signal as measured with fMRI

Secondary Outcome: Change in subjective drug effects as measured by self-report questionnaires

Study sponsors, principal investigator, and references

Principal Investigator: Stephanie C Licata, PhD

Lead Sponsor: Mclean Hospital

Collaborator: National Institute on Drug Abuse (NIDA)

More information:https://clinicaltrials.gov/show/NCT01747590

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