Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385268
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2006-10-06
Brief Title:
Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Phase II Double-Blind Placebo-controlled Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2018-09
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:
CAMPRAL
Brief Summary:
Trial to determine the safety efficacy and tolerability of acamprosate for the treatment of cocaine dependence
Detailed Description:
The primary objective of the trial is to evaluate the safety tolerability and efficacy of acamprosate for the treatment of 60 treatment seeking cocaine dependent outpatients The study will be an exploratory double-blind placebo-controlled 9-week trial with a 2-cell design 30 subjects per cell in which either 1998 mgday of acamprosate 666 mg TID or placebo will be given Study medications will be given by medical practitioners trained to provide NIAAAs COMBINE Medical Management In addition patients will receive weekly individual psychosocial treatment sessions utilizing Cognitive Behavioral Therapy CBT at the University of Pennsylvania Treatment Research Center TRC
Primary Hypotheses
1 Efficacy Acamprosate-treated subjects will demonstrate less cocaine use during the medicationplacebo treatment phase compared to placebo-treated subjects Cocaine use will be measured by self-report from the TLFB confirmed with urine assay for benzoylecgonine BE
2 Safety and Tolerability Acamprosate-treated subjects and placebo-treated subjects will report similar rates of adverse events assessed by weekly evaluations physical exams and laboratory testing
Secondary Hypotheses
1 Acamprosate-treated subjects compared to placebo-treated subjects will report less craving for cocaine measured by lower scores on the Brief Substance Craving Scale BSCS Somoza et al 1995 and Multiple Choice Procedure MCP Griffiths et al 1993 during the medication treatment phase
2 Acamprosate-treated subjects compared to placebo-treated subjects will report fewer withdrawal symptoms measured by the Cocaine Selective Severity Assessment Kampman et al 1998
3 Acamprosate-treated subjects compared to placebo-treated subjects will report fewer mood and anxiety symptoms measured by the Hamilton Depression Rating Scale HAM-D Hamilton 1967 Hamilton Anxiety Rating Scale HAM-A Hamilton 1969 and Clinical Global Impression Scale CGI
4 Subjects who are highly acamprosate-adherent 80 pills taken verified by combining patient report with blister cards will have more cocaine non-use days during the medication treatment phase compared to those who are less acamprosate-adherent 80 pills taken
Primary Hypotheses
1 Efficacy Acamprosate-treated subjects will demonstrate less cocaine use during the medicationplacebo treatment phase compared to placebo-treated subjects Cocaine use will be measured by self-report from the TLFB confirmed with urine assay for benzoylecgonine BE
2 Safety and Tolerability Acamprosate-treated subjects and placebo-treated subjects will report similar rates of adverse events assessed by weekly evaluations physical exams and laboratory testing
Secondary Hypotheses
1 Acamprosate-treated subjects compared to placebo-treated subjects will report less craving for cocaine measured by lower scores on the Brief Substance Craving Scale BSCS Somoza et al 1995 and Multiple Choice Procedure MCP Griffiths et al 1993 during the medication treatment phase
2 Acamprosate-treated subjects compared to placebo-treated subjects will report fewer withdrawal symptoms measured by the Cocaine Selective Severity Assessment Kampman et al 1998
3 Acamprosate-treated subjects compared to placebo-treated subjects will report fewer mood and anxiety symptoms measured by the Hamilton Depression Rating Scale HAM-D Hamilton 1967 Hamilton Anxiety Rating Scale HAM-A Hamilton 1969 and Clinical Global Impression Scale CGI
4 Subjects who are highly acamprosate-adherent 80 pills taken verified by combining patient report with blister cards will have more cocaine non-use days during the medication treatment phase compared to those who are less acamprosate-adherent 80 pills taken
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | OTHER | NIDA | httpsreporternihgovquickSearchP60DA005186 |
| P60DA005186 | NIH | None | None |