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Cocaine-Related DisordersPhase 2NCT00015132

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

A Phase 2 study testing Sertraline in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Cocaine-Related Disorders
What is being tested?
Sertraline
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 1999to Nov 2000
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati MDRU

    Cincinnati, Ohio, 45220

Other trials in United States

About this study

Official title: CREST-II: Tiagabine, Sertraline, or Donepezil vs. Unmatched Placebo

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.

Read the 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.

Being tested
Sertraline
Keywords
cocaine dependence
Medical subject headings
Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cocaine use

  2. Adverse events

  3. Clinical improvement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2001 (estimated)
  2. Study startMar 1999
  3. Primary completionSep 2000
  4. Study completionNov 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Intervention model
Parallel groups
Enrolment
0 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015132
Sponsor's protocol ID
NIDA-5-0012-9
Other IDs
Y01-5-0012-9
Status last verified
Mar 1999
First submitted
18 Apr 2001
Last updated
12 Jan 2017
Results posted
No

Publications

  • 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.

    PubMed 25938124

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sertraline in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cocaine use. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00015132, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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