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Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence (CAMPRAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00385268
Recruitment Status : Completed
First Posted : October 9, 2006
Results First Posted : December 31, 2013
Last Update Posted : March 20, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania

Brief Summary:
Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: acamprosate Drug: placebo Phase 2

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 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:

  1. 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)
  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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active medication Acamprosate
1998mg/day for 8 weeks
Drug: acamprosate
1998 mg/dau fpr 8 weeks
Other Name: Campral

Placebo Comparator: Placebo
placebo pills for 8 weeks
Drug: placebo
placebo pills

Primary Outcome Measures :
  1. 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)

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Male and females 18 years of age or older.
  2. Subject meets DSM-IV criteria for current diagnose of cocaine dependence, determined by The Structured Clinical Interview for DSM-IV (SCID-IV).
  3. Subject used cocaine in the past 30 days totaling at least $200 worth of cocaine. Cocaine use will be determined by utilizing the modified Timeline Followback, crosschecked with the ASI, which inquires about dollar amounts spent on drug use.
  4. Subject lives a commutable distance from the TRC and agrees to attend all research visits, including follow-up visits.
  5. Subject speaks, understands, and prints in English.
  6. Written informed consent signed by the subject.

Exclusion Criteria

  1. Subjects mandated to treatment based upon a legal decision or as a condition of employment.
  2. Subjects with evidence of current substance dependence other than cocaine, alcohol or nicotine dependence, as determined by the SCID-IV.
  3. Subjects who meets DSM-IV criteria for current alcohol dependence who require a medical alcohol detoxification.
  4. Requires treatment with any psychoactive medications, including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
  5. Has a lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia or any psychotic disorder, or organic mental disorder. Has current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation, as determined by the study physician or PI (Drs. Kyle Kampman, Charles Dackis and Helen Pettinati).
  6. 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.
  7. 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.
  8. Subjects with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (Center for Disease Control, 1986).
  9. Subjects who have any disease of the gastrointestinal tract, liver or kidneys that could result in a possibility of altered metabolism or excretion of the study drug. As it is not possible to enumerate the many conditions which might impair absorption, metabolism, or excretion, the investigators will be guided by evidence such as: History of major gastrointestinal tract surgery (gastrectomy, gastrostomy, bowel resection, etc) or a history of an active peptic ulcer or chronic disease of the GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding).
  10. History of significant heart disease (an arrhythmia which required medication, angina pectoris, documented history of myocardial infarction, or heart failure).
  11. Known hypersensitivity to acamprosate.
  12. Subjects having participated in any investigational drug trial within 30 days prior to randomizing into the study.
  13. Subjects with any serious illnesses that may require hospitalization during the study, as determined by the study physician or PI (Drs. Kyle Kampman, Charles Dackis and Helen Pettinati).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00385268

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Helen Pettinati, Ph.D. University of Pennsylvania

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Responsible Party: Kyle Kampman, Principal Investigator, University of Pennsylvania Identifier: NCT00385268    
Obsolete Identifiers: NCT00295451
Other Study ID Numbers: 803895
P60DA005186 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: October 9, 2006    Key Record Dates
Results First Posted: December 31, 2013
Last Update Posted: March 20, 2019
Last Verified: September 2018
Keywords provided by Kyle Kampman, University of Pennsylvania:
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Alcohol Deterrents