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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00183222
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 5, 2010
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date May 5, 2010
Study Start Date  ICMJE May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
  • "Natural" alcohol consumption period -- Total number of drinks consumed during the 5 day observation period
  • Pharmacological effects of alcohol consumption -- Average BAES stimulation score
  • Limited access alcohol consumption paradigm -- Total number of drinks consumed
  • Cue induced brain imaging -- Alcohol beverage cue minus neutral beverage cue activity in nucleus accumbens and insula
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
  • Change in craving as measured by the OCDS from pre-study to end of 5 day period
  • Change in craving from pre to post-alcohol ingestion
  • Change in craving during limited-access alcohol consumption
  • Change in craving during cue-induced brain activity
  • Side effects of medications
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Naltrexone and/or Ondansetron to Reduce Craving for Alcohol and Drinking
Official Title  ICMJE Alcohol Research Center Grant. Component #1. COMBINING MEDICATIONS: ALCOHOL REACTIVITY AND CONSUMPTION
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE Drug: naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
160
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion Criteria (alcohol dependent group):

  1. Age 21 65
  2. 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).
  3. Currently is not engaged in, and does not want treatment for, alcohol related problems.
  4. Able to read and understand questionnaires and informed consent.
  5. Lives within 50 miles of the study site.
  6. Able to maintain abstinence for up to three days (without the aid of detox medications) as determined by self report and breathalyzer measurements.

Inclusion Criteria (social drinker group):

  1. Age 21 65
  2. Does not meet the DSM IV criterion for lifetime or current alcohol abuse or dependence.
  3. 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.
  4. Currently is not engaged in, and does not want, treatment for alcohol related problems.
  5. Able to read and understand questionnaires and informed consent.
  6. Able to maintain abstinence for three days.

Inclusion for fMRI imaging sub-study (see methodology section for rationale):

  1. Does not have metal objects in the head/neck.
  2. Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.
  3. Between the age of 25-45 years.
  4. Does not currently smoke (note: 62% of our current sample are non-smokers).

Exclusion Criteria:

  1. Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.
  2. History of opiate abuse or a positive urine drug screen for opiates.
  3. 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.
  4. 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.
  5. Has current suicidal ideation or homicidal ideation.
  6. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications.
  7. Current use of disulfiram.
  8. Clinically significant medical problems such as, cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion.
  9. Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
  10. Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2 1/2 times normal at screening.
  11. Females of child bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
  12. Has current charges pending for a violent crime (not including DUI related offenses).
  13. Does not have a stable living situation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00183222
Other Study ID Numbers  ICMJE NIAAAANT010761-2005a
P50AA010761 ( U.S. NIH Grant/Contract )
NIH Grant P50 AA010761
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Raymond F Anton, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP