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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Pennsylvania |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00385268 |
Purpose
Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Drug: acamprosate Drug: placebo Behavioral: Cognitive Behavioral Therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence |
| Enrollment: | 60 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
1998mg/day for 8 weeks
|
Drug: acamprosate
1998 mg/dau fpr 8 weeks
Behavioral: Cognitive Behavioral Therapy
Weekly individual psychosocial treatment sessions.
|
|
2: Placebo Comparator
placebo pills for 8 weeks
|
Drug: placebo
placebo pills
Behavioral: Cognitive Behavioral Therapy
Weekly individual psychosocial treatment sessions.
|
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).
Primary Hypotheses:
Secondary Hypotheses:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using acceptable methods of birth control.
Acceptable methods of birth control include: barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, and oral contraceptives.
Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator.
EKG-1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] < 5 x ULN are acceptable. Eligibility will be determined by most recent lab results collected prior to randomization.
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Helen Pettinati, Ph.D. | University of Pennsylvania |
More Information
| Responsible Party: | University of Pennsylvania ( Helen Pettinati, Ph.D. ) |
| Study ID Numbers: | 803895, 1R01DA022220-01 |
| Study First Received: | October 6, 2006 |
| Last Updated: | December 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00385268 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cocaine |
|
Cocaine-Related Disorders Dopamine Uptake Inhibitors Neurotransmitter Agents Central Nervous System Depressants Disorders of Environmental Origin Anesthetics Cardiovascular Agents Anesthetics, Local Acamprosate |
Dopamine Mental Disorders Substance-Related Disorders Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Cocaine Ethanol |
|
Cocaine-Related Disorders Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Disorders of Environmental Origin Cardiovascular Agents Anesthetics, Local Pharmacologic Actions |
Acamprosate Sensory System Agents Mental Disorders Therapeutic Uses Substance-Related Disorders Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Cocaine Central Nervous System Agents Alcohol Deterrents |