Phase 4
Completed N=221
Pharmacogenetic Response to Naltrexone For Alcohol Dependence
Source: ClinicalTrials.gov NCT00831272 ↗Enrolled (actual)
221
Serious AEs
2.3%
Results posted
May 2017
Primary outcomePrimary: Clinical Response to Naltrexone, as Measured by a Reduction in the Percent Days of Heavy Drinking Days (as Defined by >5 Drinks/Day for Males; >4 for Females) During the 12 Weeks of the Trial. — 18.9; 17.9; 14.5; 21.7 percentage of heavy drinking days — p=0.32
Summary
The aims of the study are to test for treatment outcome differences in alcohol dependent subjects randomly assigned to 12 weeks of treatment with NTX (50mg/day) or placebo among those with one or two copies of the Asp40 allele of the mu-opioid receptor compared to those homozygous for the Asn40 allele. Thus, the design of the study is a 2X2 cell double-blind randomization to NTX or placebo stratified by genotype. To meet these aims, 150 alcohol dependent outpatients with one or two copies of the Asp40 variant of the mu-opioid receptor and 190 subjects homozygous for the Asn40 variant will be recruited across the four participating sites.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response to Naltrexone, as Measured by a Reduction in the Percent Days of Heavy Drinking Days (as Defined by >5 Drinks/Day for Males; >4 for Females) During the 12 Weeks of the Trial. |
18.9; 17.9; 14.5; 21.7 | 0.32 |
Eligibility Criteria
Inclusion Criteria
- Participant is male or female, 18 years of age or older, and of European or Asian descent.
- Participant has a current DSM-IV diagnosis of alcohol dependence using the SCID/MINI.
- The participant has signed a witnessed informed consent form.
- Participant meets the following drinking criteria as measured by the Timeline Follow Back (TLFB): a. Drinks at least an average of 21 drinks/wk in the 60-day period prior to intake and b. Has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males, 4 or more in females) in this same pre-treatment period.
- Participant has at least 48 hours of abstinence, as determined by subject report and breathalyzer measure immediately prior to randomization.
- Participant scores below 8 on the Clinical Inventory of Withdrawal from Alcohol (CIWA) prior to starting Naltrexone.
- Participant has adequate vision, hearing and ability to communicate to allow study participation.
- Participant is able to speak, print and understand English.
Exclusion Criteria
- Participant meets DSM-IV criteria for dependence on any substance other than alcohol or nicotine in the last 6 months.
- Participant has tested positive on the urine drug screen for opioids, benzodiazepines, or cocaine at the screening visit. Presence of THC is allowable.
- Participant has a current or lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia, or any psychotic disorder.
- Participant has presence of unstable or serious medical illness such as a recent stroke, idiopathic seizure disorder, or cardiac disease.
- Participant has severe liver disease (SGPT (ALT) or SGOT (AST) of at least 3 times normal value at the time of randomization or an elevated Total Bilirubin level without evidence of Gilbert's Syndrome.
- Participant has taken any psychotropic medications (including disulfiram) regularly within the last seven days (14 for fluoxetine) prior to randomization or needs immediate treatment with a psychotropic medication (antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication). EXCEPTIONS: Zolpidem and ramelteon used sparingly if necessary for sleep; Oxazepam for alcohol detoxification; Seizure disorder medications.
- Participant is over the age of 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score < 24.
- Participant meets DSM-IV criteria for current major depression (non-substance induced), PTSD, or panic disorder.
- Participant has suicidal or homicidal ideation necessitating inpatient hospitalization.
- Participant is a pre-menopausal female who is pregnant, nursing, or not using a reliable method of contraception.
- Participant is over age 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score less than 20.12. Participant is of African descent.
Data sourced from ClinicalTrials.gov (NCT00831272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.