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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00015106
First received: April 18, 2001
Last updated: November 3, 2005
Last verified: February 1999
  Purpose

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 Intervention Phase
Cocaine-Related Disorders
Drug: Lamotrigine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: CREST-I: Resperine, Gabapentin, or Lamotrigine Vs. Placebo

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Urine toxicology for cocaine
  • Adverse events
  • Clinical improvement

Estimated Enrollment: 0
Study Start Date: November 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015106

Locations
United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
Investigators
Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati MDRU
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00015106     History of Changes
Other Study ID Numbers: NIDA-5-0012-7, Y01-5-0012-7
Study First Received: April 18, 2001
Last Updated: November 3, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Anticonvulsants
Lamotrigine
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 24, 2014