Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence (CAMPRAL)
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|ClinicalTrials.gov Identifier: NCT00385268|
Recruitment Status : Completed
First Posted : October 9, 2006
Results First Posted : December 31, 2013
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: acamprosate Drug: placebo||Phase 2|
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 mg/day of acamprosate (666 mg TID) or placebo will be given. Study medications will be given by medical practitioners, trained to provide NIAAA's 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).
- Efficacy: Acamprosate-treated subjects will demonstrate less cocaine use during the medication/placebo 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)
- 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.
- 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.
- Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer withdrawal symptoms, measured by the Cocaine Selective Severity Assessment (Kampman et al., 1998).
- 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).
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II, Double-Blind, Placebo-controlled, Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||July 2008|
Experimental: Active medication Acamprosate
1998mg/day for 8 weeks
1998 mg/dau fpr 8 weeks
Other Name: Campral
Placebo Comparator: Placebo
placebo pills for 8 weeks
- Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen [ Time Frame: 8 weeks ]cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)
- Urine Benzoylecgonine Tests (UBT) [ Time Frame: 8 weeks ]The primary outcome measure for this trial was qualitative urine benzoylecgonine tests (UBT) obtained twice weekly. Urine collection was monitored by temperature checks. Samples less than 90 degrees, or greater than 100 degrees Fahrenheit were considered invalid and were not accepted. Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385268
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Helen Pettinati, Ph.D.||University of Pennsylvania|