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

NCT00015106 | Completed Phase 2

• 2 other identifiers: NIDA-5-0012-7Y01-5-0012-7
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (3)

• Urine toxicology for cocaine

• Adverse events

• Clinical improvement

Interventions

Lamotrigine DRUG

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Current dependence on any psychoactive substance other than cocaine, alcohol, or nicotine, physiological dependence on alcohol requiring medical detoxification.
• Subjects requiring treatment for neurological or psychiatric disorders.
• Subjects with any potentially life threatening or progressive medical illness other than addiction.
• Subjects with a history of hypertension currently requiring treatment.
• 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.
• 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.
• Subjects who have clinically significant abnormal laboratory values as determined by the principal investigator.
• Subjects who have any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication.
• Chronic therapy with any medication which could interact adversely with one of the medications under study.
• Therapy with any of the opiate-substitutes (methadone, LAAM, buprenorphine) within 60 days of enrollment in this study.
• Subjects with a seizure disorder or with a history of a seizure disorder other than childhood febrile seizures or alcohol withdrawal seizures.
• Subjects with a history of major depression.
• Patients with a history of rashes or other sensitivity reactions to reserpine, lamotrigine, or gabapentin.
• Participant plans to receive psychosocial treatment external to that designated in the protocol during study participation.
• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Cincinnati MDRU

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.

  PMID: 25938124 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eugene Somoza, M.D., Ph.D.

  Cincinnati MDRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 18, 2001
• First Posted: April 18, 2001
• Study Start: November 1, 1997
• Primary Completion: January 1, 1999
• Study Completion: February 1, 1999
• Last Updated: January 12, 2017

Record last verified: 1999-02

Locations

US (1)