Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167687
Status:
COMPLETED
Last Update Posted:
2008-02-15
First Post:
2005-09-09
Brief Title:
Prazosin Alcohol Dependence IVR Study
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of Prazosin for the Treatment of Alcohol Dependence
Status:
COMPLETED
Status Verified Date:
2008-02
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:
This double-blind placebo controlled pilot trial will test the hypothesis that prazosin an alpha-1 adrenergic receptor antagonist reduced alcohol consumption and alcohol craving in alcohol dependent individuals without Post Traumatic Stress Disorder PTSD The intervention period is six weeks
Detailed Description:
The objective of the project is to determine whether prazosin an alpha-1 adrenergic receptor antagonist decreases alcohol consumption andor the subjective experience of alcohol craving in individuals without post-traumatic stress disorder PTSD who are seeking treatment for alcohol dependence
The study hypotheses are 1 Subjects treated with prazosin will report fewer drinking days and fewer drinks per drinking day than subjects treated with placebo 2 subjects treated with prazosin will report decreased craving for alcohol as compared to subjects in the placebo condition and 3 prazosin will be well-tolerated at the proposed dosage by subjects in the prazosin condition compared to subjects in the placebo condition
This project is a double-blind randomized placebo-controlled trial of prazosin in subjects who are dependent on alcohol and have used alcohol within the last 30 days prior to randomization The treatment phase will last 6 weeks and will include 40 subjects 20 randomized to each experimental condition prazosin and placebo Participants in both the groups will be provided the same behavioral treatment for alcohol dependence throughout the course of the study Participants in both groups will also use daily Interactive Voice Response IVR symptom monitoring technology to track daily fluctuations in alcohol use and craving as well as medication compliance
The study will be conducted at the Addiction Treatment Center ATC at VAPSHCS Seattle division
Participants will include 40 alcohol-dependent adults presenting for chemical dependency treatment at the VA Puget Sound Health Care System VAPSHCS Addiction Treatment Center as well as subjects recruited from the general public via advertisements in local weekly newspapers
Study Procedures Once potential study participants have undergone an initial screen to insure basic eligibility they will provide informed consent and will undergo a 2-hour baseline assessment that will include completing a diagnostic interview paper-and-pencil packet of measures and providing urine and blood specimens After completion of these assessments a final determination will be made within three business days as to whether the potential participant meets inclusion but not exclusion criteria Eligible participants will then be randomized to one of the two treatment groups The participants will be prompted three times each day by text messaging pages reminding them to take their study medications
The behavioral treatment to be used in this study is the Medication Management protocol adapted from the procedure used in Project COMBINE A clinical rescue strategy will be in place such that any participants who evidence severe clinical deterioration including consuming more than 140 standard equivalent drinks in any 7 day period will be removed from the protocol and offered inpatient treatment at VA PSHCS
During the first two weeks of the study participants will have twice-weekly orthostatic vital sign and adverse events monitoring by the study nurse or physician then weekly thereafter All serious or unexpected adverse events will be reported to the FDA and UW Human Subjects Committee in accordance with requirements When participants have completed their medication treatment at 6 weeks post-randomization they will repeat all the baseline measures and laboratory tests urine and blood samples will be requested except for the PCL and the California Verbal Learning Test
The study hypotheses are 1 Subjects treated with prazosin will report fewer drinking days and fewer drinks per drinking day than subjects treated with placebo 2 subjects treated with prazosin will report decreased craving for alcohol as compared to subjects in the placebo condition and 3 prazosin will be well-tolerated at the proposed dosage by subjects in the prazosin condition compared to subjects in the placebo condition
This project is a double-blind randomized placebo-controlled trial of prazosin in subjects who are dependent on alcohol and have used alcohol within the last 30 days prior to randomization The treatment phase will last 6 weeks and will include 40 subjects 20 randomized to each experimental condition prazosin and placebo Participants in both the groups will be provided the same behavioral treatment for alcohol dependence throughout the course of the study Participants in both groups will also use daily Interactive Voice Response IVR symptom monitoring technology to track daily fluctuations in alcohol use and craving as well as medication compliance
The study will be conducted at the Addiction Treatment Center ATC at VAPSHCS Seattle division
Participants will include 40 alcohol-dependent adults presenting for chemical dependency treatment at the VA Puget Sound Health Care System VAPSHCS Addiction Treatment Center as well as subjects recruited from the general public via advertisements in local weekly newspapers
Study Procedures Once potential study participants have undergone an initial screen to insure basic eligibility they will provide informed consent and will undergo a 2-hour baseline assessment that will include completing a diagnostic interview paper-and-pencil packet of measures and providing urine and blood specimens After completion of these assessments a final determination will be made within three business days as to whether the potential participant meets inclusion but not exclusion criteria Eligible participants will then be randomized to one of the two treatment groups The participants will be prompted three times each day by text messaging pages reminding them to take their study medications
The behavioral treatment to be used in this study is the Medication Management protocol adapted from the procedure used in Project COMBINE A clinical rescue strategy will be in place such that any participants who evidence severe clinical deterioration including consuming more than 140 standard equivalent drinks in any 7 day period will be removed from the protocol and offered inpatient treatment at VA PSHCS
During the first two weeks of the study participants will have twice-weekly orthostatic vital sign and adverse events monitoring by the study nurse or physician then weekly thereafter All serious or unexpected adverse events will be reported to the FDA and UW Human Subjects Committee in accordance with requirements When participants have completed their medication treatment at 6 weeks post-randomization they will repeat all the baseline measures and laboratory tests urine and blood samples will be requested except for the PCL and the California Verbal Learning Test
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