Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00667771 · ClinicalTrials.gov registry record · Early Phase 1
The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion
A Early Phase 1 study of Alcoholism and Alcohol Dependence, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT00667771 is a Early Phase 1 study of Alcoholism and Alcohol Dependence that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 70 participants, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00667771, a Early Phase 1 study of Alcoholism and Alcohol Dependence, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen the craving for alcohol during alcohol withdrawal and examine how the drug affects brain activity during alcohol infusion. People between 21 and 50 years of age who are right-handed, alcohol-dependent, and have at least one family member with a history of alcoholism, may be eligible for this study. Participants are admitted to the NIH Clinical Center for 1 month for the following procedures: Screening * Medical history, alcohol-use history and family history of alcoholism * Physical examination, psychological tests and blood tests * Medicine to lessen alcohol withdrawal symptoms, if necessary Days 1-7 * Alcohol detoxification * Medical and psychological evaluations * Assignment to naltrexone or placebo group Days 7 through 28 * Drug treatment: Take naltrexone or placebo capsule every morning * Additional alcohol-dependence treatment: Cognitive and behavioral therapies and participation in self-help groups, such as Alcoholics Anonymous * Weekly questionnaires to measure mood and desire for alcohol * Blood tests * Alcohol craving stimulation test (day 7): Subjects handle and sniff water and then their favorite alcoholic beverage. They then rate their urge to drink alcohol and their level of anxiety and their heart rate is measured. * Alcohol infusion test (day 9): Subjects have an MRI scan during infusion through a vein of saline (salt water), followed by infusion of alcohol. For this test, a catheter (plastic tube) is placed in a vein in each arm, one for administering the saline and then alcohol; the other for drawing blood samples to measure blood alcohol level and body chemistries. Before, during and after the infusion, subjects are asked to respond to questions about their feelings, cravings and mood changes. Follow-up Subjects are asked to participate in a 3-month outpatient assessment program involving five outpatient visits (at 1, 2, 4, 8 and 12 weeks after
Conditions Studied
Interventions
- DRUG Naltrexone
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2008-04-22 |
| Est. Completion | 2011-04-04 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00667771
The ClinicalTrials.gov registry entry for NCT00667771 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (81% lower). The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alcoholism appearing as the primary indexed condition, and to 1 intervention - of which Naltrexone is the first listed.
NCT00667771 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00667771 about?
NCT00667771 is a clinical study titled "The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion". This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen the craving for alcohol during alcohol withdrawal and examine how the drug affects brain activity during alcohol infusion. People between 21 and 50 years of age who are right-handed, alcohol-dependent, and...
What is the current status of trial NCT00667771?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 70 participants. The study started on 2008-04-22. Estimated completion is 2011-04-04.
What conditions does trial NCT00667771 study?
This clinical trial studies the following conditions: Alcoholism, Alcohol Dependence.
What interventions are being tested in trial NCT00667771?
The interventions under investigation include: Naltrexone (DRUG).
Who is sponsoring clinical trial NCT00667771?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00667771 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcoholism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Behavioral Alcohol Responses (BAR) Study
ACTIVE NOT RECRUITING · Early Phase 1
-
The Effects of Oxytocin on Startle Hyperreactivity in Patients With AUD and PTSD
COMPLETED · Early Phase 1
-
Naltrexone in AUD Reward Drinkers
RECRUITING · Phase 4
-
Characterization Imaging Instruments in Alcoholics and Non-Alcoholics
RECRUITING
-
Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder
RECRUITING · NA
-
Alcohol and the Social Brain: an Alcohol-Administration Hyperscanning Study
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.