Resperine, Gabapentin, or Lamotrigine for the Treatment of Cocaine Dependence: 2 - 7

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: NCT00015106
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 treatment of cocaine dependence using reserpine, gabapentin, or lamotrigine vs. an unmatched placebo control.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Lamotrigine 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, 60-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 reserpine, gabapentin and lamotrigine. Reserpine is being screened because of its well-known preclinical ability to functionally antagonize cocaine (by depleting neurochemicals elevated by cocaine). Gabapentin and lamotrigine are hypothesized to interfere with glutamatergic cocaine sensitization/kindling mechanisms relevant to addiction.

Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: CREST-I: Resperine, Gabapentin, or Lamotrigine vs. Placebo
Study Start Date : November 1997
Actual Primary Completion Date : January 1999
Actual Study Completion Date : February 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Urine toxicology for cocaine
  2. Adverse events
  3. Clinical improvement

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and females, 18 to 59 years of age.
  2. DSM-IV diagnosis of cocaine dependence as determine by a semi-structured clinical interview.
  3. Subjects must have at least two cocaine-positive urines (BE level >300 ng/ml) during the two week screening phase of the study.
  4. Subjects must have a self reported use of at least $100 worth of cocaine within the past 30 days.
  5. Ability to provide written informed consent and to comply with all study procedures.
  6. 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

Exclusion Criteria:

  1. Current dependence on any psychoactive substance other than cocaine, alcohol, or nicotine, physiological dependence on alcohol requiring medical detoxification.
  2. Subjects requiring treatment for neurological or psychiatric disorders.
  3. Subjects with any potentially life threatening or progressive medical illness other than addiction.
  4. Subjects with a history of hypertension currently requiring treatment.
  5. Subjects who have received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment or who have been on any experimental medication within the past 60 days.
  6. Females who are pregnant or lactating or having had three or more days of amenorrhea beyond the time of expected menses at the time of the first dose of study medication.
  7. Subjects who have clinically significant abnormal laboratory values as determined by the principal investigator.
  8. Subjects who have any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication.
  9. Chronic therapy with any medication which could interact adversely with one of the medications under study.
  10. Therapy with any of the opiate-substitutes (methadone, LAAM, buprenorphine) within 60 days of enrollment in this study.
  11. Subjects with a seizure disorder or with a history of a seizure disorder other than childhood febrile seizures or alcohol withdrawal seizures.
  12. Subjects with a history of major depression.
  13. Patients with a history of rashes or other sensitivity reactions to reserpine, lamotrigine, or gabapentin.
  14. Participant plans to receive psychosocial treatment external to that designated in the protocol during study participation.
  15. Subjects with systolic blood pressure below 100 mm of Hg., or diastolic blood pressure below 60 mm of Hg., who are symptomatic as determined by the physician conducting the screening medical history and phy

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): NCT00015106

United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati MDRU

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00015106     History of Changes
Other Study ID Numbers: NIDA-5-0012-7
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: February 1999

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
Anesthetics, Local
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors