Recruiting
Early Phase 1

Zolpidem & Alprazolam

Sponsor:

Mclean Hospital

Code:

NCT01747590

Conditions

Psychotropic Drugs Effects

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

Interventions

Zolpidem

Alprazolam

Caffeine

Placebo

Study Details

Brief summary:

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.

Conditions

Psychotropic Drugs Effects

Study ID

NCT01747590

Start date

Jul, 2011

Status verified date

Dec, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Zolpidem, Alprazolam, Caffeine, and Placebo

The 4 medications are given in a counterbalanced design.

Interventions

Zolpidem

Alprazolam

Caffeine

Placebo

Primary outcome measure

  • Change in blood oxygen level-dependent (BOLD) signal as measured with fMRI [ Time Frame: 45 min after drug administration ]

Central Contacts and Locations

Central contacts

Nina A Conn, BA

617-855-2902nconn@mclean.harvard.edu

Stephanie C Licata, PhD

617-855-2738slicata@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Nina A Conn, BA

617-855-2902nconn@mclean.harvard.edu

Principal Investigator:

Stephanie C Licata, PhD

More Information

Sponsor

Mclean Hospital

Last update posted

Dec 11, 2012

Last verified

Dec, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2012-12-11.