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

NCT00015132 | Completed Phase 2

• 2 other identifiers: NIDA-5-0012-9Y01-5-0012-9
• 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 use of tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified placebo-controlled experimental design.

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (3)

• Cocaine use

• Adverse events

• Clinical improvement

Interventions

Sertraline DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females, 18 to 60 years of age.
• DSM-IV diagnosis of cocaine dependence as determined by a semi-structured psychiatric evaluation.
• Use of at least $100 worth of cocaine within the past 30 days.
• 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.
• 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).
• 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, f.complete abstinence

You may not qualify if:

• Dependence on psychoactive substance other than cocaine, alcohol, or nicotine. Physiological dependence on alcohol requiring medical detox.
• Neurological or psychiatric disorders which require treatment or which would make medication compliance difficult.
• Serious medical illnesses that may compromise patient safety or study conduct.
• 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.
• 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.
• Women of childbearing capacity who are not on a medically accepted method of birth control.
• Clinically significant abnormal laboratory values.
• 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.
• 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.
• Receiving therapy with any of the opiate-substitutes within 60 days of enrollment in this study.
• 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.
• Using albuterol or other beta agonist medications, regardless of whether they are diagnosed with asthma.
• For individuals who may be suspect for asthma but carry no diagnosis (exclude if on beta agonists). Patients with FEV1 \<70 should be excluded.
• History of rashes or other sensitivity reactions to study meds.
• Plans to receive psychosocial treatment external to that designated in the protocol.

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

Sertraline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic 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: March 1, 1999
• Primary Completion: September 1, 2000
• Study Completion: November 1, 2000
• Last Updated: January 12, 2017

Record last verified: 1999-03

Locations

US (1)