AzTrials
AzTrials

Alcohol DependencePhase 2NCT00183222

Effectiveness of Naltrexone and/or Ondansetron to Reduce Craving for Alcohol and Drinking

A Phase 2 study testing naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days in people with Alcohol Dependence, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence), ondansetron a serotonin 3 antagonist medication approved to treat nausea) or their combination are effective in the reduction of alcohol craving and drinking compared to placebo. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Dependence
What is being tested?
naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days
How many people
160 participants
Where
1 siteUnited States
Study dates
May 2005to Dec 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 21 65
  • Meets the DSM IV criterion for current alcohol dependence including "loss of control over drinking" (criterion 4) but does not necessarily have signs of physiologic dependence as expressed in criterion for tolerance development (criterion 1) and withdrawal symptoms or use to avoid withdrawal symptoms (criterion 2).
  • Currently is not engaged in, and does not want treatment for, alcohol related problems.
  • Able to read and understand questionnaires and informed consent.
  • Lives within 50 miles of the study site.
  • Able to maintain abstinence for up to three days (without the aid of detox medications) as determined by self report and breathalyzer measurements.
Show all 17Show fewer
  • Age 21 65
  • Does not meet the DSM IV criterion for lifetime or current alcohol abuse or dependence.
  • Consumes, on average, less than 14 standard drinks per week. But has consumed at least 2 standard drinks on at least one occasion in the last month.
  • Currently is not engaged in, and does not want, treatment for alcohol related problems.
  • Able to read and understand questionnaires and informed consent.
  • Able to maintain abstinence for three days.
  • Inclusion for fMRI imaging sub-study (see methodology section for rationale):
  • Does not have metal objects in the head/neck.
  • Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.
  • Between the age of 25-45 years.
  • Does not currently smoke (note: 62% of our current sample are non-smokers).

Who cannot join

  • Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.
  • History of opiate abuse or a positive urine drug screen for opiates.
  • Any psychoactive substance use (except marijuana and nicotine) within the last 30 days as evidenced by self-report and urine drug screen. For marijuana -no use within the last seven days.
  • Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders and eating disorders, any other psychotic disorder or organic mental disorder.
  • Has current suicidal ideation or homicidal ideation.
  • Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications.
Show all 13Show fewer
  • Current use of disulfiram.
  • Clinically significant medical problems such as, cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion.
  • Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
  • Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2 1/2 times normal at screening.
  • Females of child bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
  • Has current charges pending for a violent crime (not including DUI related offenses).
  • Does not have a stable living situation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Drug and Alcohol Programs, Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Alcohol Research Center Grant. Component #1. COMBINING MEDICATIONS: ALCOHOL REACTIVITY AND CONSUMPTION

The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence), ondansetron a serotonin 3 antagonist medication approved to treat nausea) or their combination are effective in the reduction of alcohol craving and drinking compared to placebo.

Read the detailed description

Non-treatment seeking individuals meeting criteria for alcohol dependence N=160) will be recruited through advertisement and paid for their participation. Alcoholics, after baseline evaluation, will be assigned through urn randomization (using a double dummy placebo controlled design) to one of four experimental groups, naltrexone (50 mg/day) (N=40), ondansetron (0.25 mg twice a day) (N=40), naltrexone and ondansetron (N=40) or placebos (N=40). Subjects will take the study drugs for 8 days (day 1-5 being the natural observation period). After a minimum of 48 hours of abstinence from alcohol day 6-8) they will undergo an alcohol administration (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end of the study to enhance their awareness of problem drinking and to motivate them to seek treatment. Referral for treatment will be offered.A subset of subjects from each medication group (N=15) will undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm.

A smaller group of social drinker controls (N=16), recruited and paid in a similar fashion, will be randomly assigned to the same medication groups (4 per group). They will be used as procedure controls for the alcohol administration lab study and as a comparison/contrast group for the brain imaging sub-study.

Being tested
naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days
Keywords
Alcohol dependence, Alcoholism, Craving
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 daysDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. "Natural" alcohol consumption period -- Total number of drinks consumed during the 5 day observation period

  2. Pharmacological effects of alcohol consumption -- Average BAES stimulation score

  3. Limited access alcohol consumption paradigm -- Total number of drinks consumed

  4. Cue induced brain imaging -- Alcohol beverage cue minus neutral beverage cue activity in nucleus accumbens and insula

Secondary outcomes (5)

  1. Change in craving as measured by the OCDS from pre-study to end of 5 day period

  2. Change in craving from pre to post-alcohol ingestion

  3. Change in craving during limited-access alcohol consumption

  4. Change in craving during cue-induced brain activity

  5. Side effects of medications

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
160 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00183222
Sponsor's protocol ID
NIAAAANT010761-2005a
Other IDs
P50AA010761, NIH Grant P50 AA010761
Status last verified
May 2010
First submitted
13 Sep 2005
Last updated
5 May 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days in people with Alcohol Dependence, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

"Natural" alcohol consumption period -- Total number of drinks consumed during the 5 day observation period. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00183222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in