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Tiagabine, Sertraline, or Donepezil for the Treatment of Cocaine Dependence - 9

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: NCT00015132
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified placebo-controlled experimental design.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Sertraline Phase 2

Detailed Description:

Considerable progress in preclinical research has provided a basis for hypothesis driven clinical trials in cocaine dependence. A greater mechanistic understanding of both cocaine and many clinically approved medications has led to the identification of many promising medications for the treatment of cocaine dependence.

For this reason NIDA has developed a CREST (Clinical Rapid Evaluation Screening Trial) protocol to provide a needed incremental medication screening step between preclinical research and full blown expensive Phase III pivotal trials. While patients receive manual based psychotherapy, three medications are screened compared to unmatched placebo in an eight-week, 80-subject, four cell design trial. Other important features of the CREST protocol include collecting baseline measurements over a two week period and analyzing primary outcome measures (quantitative urine toxicology and clinical global improvement scales) in terms of a composite score of overall individual patient improvement.

The three medications being evaluated in this trial include tiagabine, sertraline, and donepzil. Tiagabine is hypothesized to interfere with glutamatergic cocaine mechanisms relevant to addiction. Sertraline is a potent and selective inhibitor of neuronal 5-HT reuptake, which may modulate the reinforcing and cueing effects of cocaine. Donepezil is hypothesized to interfere with cholinergic cocaine mechanisms relevant to addiction.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: CREST-II: Tiagabine, Sertraline, or Donepezil vs. Unmatched Placebo
Study Start Date : March 1999
Actual Primary Completion Date : September 2000
Actual Study Completion Date : November 2000

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cocaine use
  2. Adverse events
  3. Clinical improvement

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and females, 18 to 60 years of age.
  2. DSM-IV diagnosis of cocaine dependence as determined by a semi-structured psychiatric evaluation.
  3. Use of at least $100 worth of cocaine within the past 30 days.
  4. Substantiated current cocaine use demonstrated by six urine toxicology specimens, two of which are positive for BE, in a consecutive two week period during the 30 days prior to study entry. No more than 4 specimens within seven days will be collected.
  5. Additional baseline measures must be completed in conjunction with urine specimens described in #4, which include: once weekly craving measure (BSCS), Self and Observer Global ratings, semiquantitative urine specimen for toxicology of six substances (amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates); and three times weekly alcohol breathalyzer and Self Report of Drug Use (SUR).
  6. Ability to provide written informed consent and to comply with all study procedures.
  7. Women of child-bearing capacity must be using one of the following acceptable methods of birth-control: a. oral contraceptives, b. barrier (diaphragm or condom) with spermicide, c. intrauterine progesterone contraceptive system, d. levonorgestrel implant, e. medroxyprogesterone acetate contraceptive injection, f.complete abstinence

Exclusion Criteria:

  1. Dependence on psychoactive substance other than cocaine, alcohol, or nicotine. Physiological dependence on alcohol requiring medical detox.
  2. Neurological or psychiatric disorders which require treatment or which would make medication compliance difficult.
  3. Serious medical illnesses that may compromise patient safety or study conduct.
  4. Receiving a drug with known potential for toxicity to a major organ system within the month prior to entering treatment or being on any experimental medication within the past 60 days.
  5. Women who are pregnant, lactating, have had three or more days of amenorrhea beyond the time of expected menses at the time of the first dose of study medication.
  6. Women of childbearing capacity who are not on a medically accepted method of birth control.
  7. Clinically significant abnormal laboratory values.
  8. Any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication or history or diagnosis of chronic disease of the gastrointestinal tract.
  9. Receiving chronic therapy with any medication which could interact adversely with one of the study medications.In particular patients must not have used MAO inhibitors within 60 days of dosing.
  10. Receiving therapy with any of the opiate-substitutes within 60 days of enrollment in this study.
  11. The diagnosis of adult asthma, including those with a history of acute asthma within the past two years, and those with current or recent (past 2 years) treatment with inhaled or oral beta-agonists or steroid therapy.
  12. Using albuterol or other beta agonist medications, regardless of whether they are diagnosed with asthma.
  13. For individuals who may be suspect for asthma but carry no diagnosis (exclude if on beta agonists). Patients with FEV1 <70 should be excluded.
  14. History of rashes or other sensitivity reactions to study meds.
  15. Plans to receive psychosocial treatment external to that designated in the protocol.

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): NCT00015132

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United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati MDRU
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00015132    
Obsolete Identifiers: NCT00015145, NCT00015158
Other Study ID Numbers: NIDA-5-0012-9
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: March 1999
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs