Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223275
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2005-09-15
Brief Title:
Naltrexone for Bipolar Disorder and Alcohol Dependence
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Naltrexone for Bipolar Disorder and Alcohol Dependence
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The abuse of alcohol is especially common in people with bipolar disorder However very little is known about how to treat people with both bipolar disorder and alcohol abusedependence The purpose of this research is to determine whether naltrexone add-on therapy is associated with a greater reduction in alcohol use and alcohol craving than with placebo an inactive substance therapy
Detailed Description:
A 12-week randomized double-blind parallel-group placebo-controlled trial of naltrexone will be conducted in 50 English- or Spanish-speaking outpatients with bipolar I disorder or II disorder and current alcohol dependence At the baseline appointment informed consent will be obtained and assessment procedures including a review of inclusion and exclusion criteria will be performed The SCID Structured Clinical Interview for DMS-IV Axis I Disorders will be performed to establish the diagnoses of bipolar I or II disorder and alcohol dependence A psychiatrist will confirm the SCID diagnoses obtained by the RA Eligible participants will then be given the Hamilton Rating Scale for Depression 17-item version HRSD17 Inventory of Depressive Symptomatology-Self-Report 30-item version IDS-SR30 Young Mania Rating Scale YMRS Penn Alcohol Craving Scale PACS Addiction Severity Index ASI Psychobiology of Recovery in Depression III Somatic Symptom Scale PRD-III and a urine drug screen Recent alcohol use and if present other substance use will be assessed using the Timeline Followback TLFB method with a drink defined as 136g of absolute alcohol approximately 12 oz 341 mL of beer 5 oz of wine 3 oz of fortified wine or 15 oz of 80 proof liquor Length of problem alcohol use will be assessed by asking When did alcohol first start causing you problems Blood will be drawn for routine laboratory analyses including a complete blood count CBC and SMA-20 includes a liver panel with GGT AST ALT Billirubin at baseline week 0 and completion week 12 Blood will also be drawn at weeks 4 and 8 for repeat testing of GGT levels A physical examination will be performed at baseline Women of childbearing potential will receive a urine pregnancy test and will be counseled about effective contraceptive methods A psychiatrist will assess the participants at baseline and weekly follow-up visits and will participate in the informed consent process Study medication will be given at a second appointment after results of the liver function tests have been received generally 1-2 days after the first appointment At each weekly assessment the HRSD17 IDS-R30 YMRS an assessment of alcohol use in the past week and a urine drug screen will again be obtained Urine drug screen will be obtained only from the newly enrolled subjects We will not obtain urine drug screens from subjects who are already active in the study In addition all participants will receive a total of 16 one-hourweek sessions of manual-driven CBT specifically designed for persons with bipolar disorder and substance abuse provided by a bilingual psychologist with experience in CBT Patients will discontinue study medication at week 12 but continue their CBT therapy until week 16 Pill counts will be conducted at each weekly assessment visit In addition during weekly assessments participants will be asked about adherence with other psychotropic medications using a modified version of an assessment developed by Weiss et al and the estimated percent of prescribed medication actually taken will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None