Alcoholism
Conditions
Keywords
Alcohol, Alcohol Dependence, Alcoholism
Brief summary
This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.
Detailed description
We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.
Interventions
DRUGOndansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Ondansetron 4 ug/kg b.i.d.for 12 weeks
DRUGNaltrexone 50 mg/day + Cognitive Behavioral Therapy
Naltrexone 50 mg/day for 12 weeks
DRUGOndansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks
Placebo comparator
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Bankole Johnson
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females who have given written informed consent. * Ages 18 years and above and must weigh at least 40 kg and no more than 140 kg. * Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters (see
Exclusion criteria
). * Current DSM-IV diagnosis of alcohol dependence * AUDIT score of equal or more than 8. * Currently drinking * Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next three months. * The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide. * Literate in English and able to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments. * Answer an advertisement in the newspaper/radio/television, or be referred from a health care professional and express a wish to stop drinking. * Willingness to participate in behavioral treatments for alcoholism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption | Throughout the study | Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors | Throughout the study | Pill Count, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM |
Countries
United States
Outcome results
None listed