Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260481
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2005-11-29
Brief Title:
Prometa Pharmacotherapy for Methamphetamine Dependence
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Double-Blind Placebo Controlled Trial of Prometa Pharmacotherapy for the Treatment of Methamphetamine Abuse
Status:
COMPLETED
Status Verified Date:
2016-01
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 purpose of this study is to assess the efficacy of the PROMETA pharmacotherapy compared to placebo for initiating abstinence and for preventing relapse to methamphetamine use in treatment-seeking individuals meeting criteria for methamphetamine abuse It is hypothesized that individuals assigned to receive the PROMETA pharmacotherapy compared to placebo will demonstrate significantly fewer and less intense withdrawal symptoms more days abstinent from methamphetamine use and fewer relapses to methamphetamine use as assessed by self-report of drug use verified by urine samples
Detailed Description:
Using a double-blind placebo design the effectiveness of the Prometa protocol for methamphetamine dependence will be investigated as compared to a placebo condition The procedure utilizes a combination of medications delivered both orally and by infusion in a controlled medical setting Participants will be randomly assigned to the active medication or placebo condition and will receive medications for 40 days including two inpatient hospitalization phases of three days each All participants will also receive once-weekly psychosocial cognitive-behavioral therapy throughout the 106 day study duration A variety of data will be collected throughout the study including psychological cognitive medical and laboratory assessments
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