Cocaine-Related DisordersPhase 1NCT00124696
Cocaethylene as a Treatment for Cocaine Dependence - 1
A Phase 1 study testing Cocaethylene in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Cocaine has been cited as the primary drug threat in the United States. The purpose of this study is to determine if cocaethylene, used as a prototype drug, is a safe and effective treatment for cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Cocaethylene
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Mar 2005
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets DSM-IV criteria for cocaine dependence
- Cocaine use of at least 0.5 grams each week during the three months prior to enrollment, confirmed by a positive urine test for cocaine metabolite
- Females are eligible if currently using adequate contraception, not planning to become pregnant, or surgically sterilized
- Females of child-bearing potential must have a negative pregnancy test prior to study entry
- Currently not physiologically dependent on alcohol, but may meet DSM-IV criteria for alcohol abuse or dependence
Who cannot join
- Meets DSM-IV criteria for dependence on any drugs (other than nicotine or alcohol) within the year prior to enrollment
- Currently abuses other substances such as opiates, sedative-hypnotics, or amphetamines (excluding marijuana or nicotine) more than twice a week
- History of a serious medical illness or indication of a serious medical illness such as seizures, hypertension, heart disease, an abnormal ECG, anemia, diabetes, or abnormal blood flow sounds
- Meets DSM-IV criteria for a current major mental disorder, including major depression, bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or organic mental syndrome
- Currently being treated with psychotropic medication
- At risk for suicide, as determined by a psychiatrist
Show all 9Show fewer
- Greater than two times the normal level for liver or kidney function tests
- Currently seeking treatment for drug abuse
- Participants with liver function tests equal to or greater than three times the normal level will be discontinued from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Cocaethylene Substitution Therapy and Tolerance Induction in Treating Cocaine Dependence
Cocaine has been cited as the primary drug threat in the United States. The purpose of this study is to determine if cocaethylene, used as a prototype drug, is a safe and effective treatment for cocaine dependence.
Read the detailed description
Currently, there are no medications available to specifically treat cocaine addiction. Cocaethylene is an active metabolite of cocaine and has a similar chemical structure to cocaine. The purpose of this study is to determine whether substitution therapy with cocaethylene is a safe and effective treatment for cocaine dependence.
This double-blind, placebo-controlled trial will occur in 3 parts. In Part 1, the individual pharmacokinetics of an intravenous dose of cocaethylene will be determined in order to estimate individualized cocaethylene infusion rates and pharmacokinetic parameters. This will provide important information on how cocaethylene is processed by the body. In Part 2, an infusion of cocaethylene, producing a venous plasma concentration of 200 ng/ml, will be administered over an 8-hour period. Clinical monitoring and blood sampling will occur in order to determine the safety profile of cocaethylene. During Part 3, the ability of cocaethylene to modify the acute effects of intravenous cocaine will be determined. Cocaethylene will be administered in plasma concentrations of 0 ng/ml, 50 ng/ml, or 200 ng/ml over an 8-hour period. Participants will be randomly assigned to receive a challenge intravenous dose of cocaine (0.5 mg/kg or 1 mg/kg) or placebo at the 4-hour mark of cocaethylene infusion. Following the initial 8-hour period, cocaethylene infusion will be continued for an additional 5 hours. Behavioral and physiological measures will be collected throughout the study sessions at predetermined times to evaluate whether tolerance to cocaethylene develops. These measures will also help to determine whether cocaethylene modifies or produces tolerance to the effects of an acute dose of cocaine.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Cocaethylene
- 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.
CocaethyleneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical physiological response to cocaine challenge - especially adverse effects measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startDec 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 8 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elinore Mccance-Katz, M.D., Ph.D., Principal investigator, Yale Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124696
- Sponsor's protocol ID
- NIDA-13586-1
- Other IDs
- R01-13586-1, DPMC
- Status last verified
- Aug 2005
- First submitted
- 22 Jul 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cocaethylene Substitution Therapy and Tolerance Induction in Treating Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00124696
- Acronym / sponsor ID
- NIDA-13586-1
- Conditions
- Cocaine-Related Disorders
- Keywords
- cocaine dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Dec 2002
- Study completion
- Mar 2005
- First posted
- 28 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cocaine has been cited as the primary drug threat in the United States. The purpose of this study is to determine if cocaethylene, used as a prototype drug, is a safe and effective treatment for cocaine dependence.
Detailed description
Currently, there are no medications available to specifically treat cocaine addiction. Cocaethylene is an active metabolite of cocaine and has a similar chemical structure to cocaine. The purpose of this study is to determine whether substitution therapy with cocaethylene is a safe and effective treatment for cocaine dependence.
This double-blind, placebo-controlled trial will occur in 3 parts. In Part 1, the individual pharmacokinetics of an intravenous dose of cocaethylene will be determined in order to estimate individualized cocaethylene infusion rates and pharmacokinetic parameters. This will provide important information on how cocaethylene is processed by the body. In Part 2, an infusion of cocaethylene, producing a venous plasma concentration of 200 ng/ml, will be administered over an 8-hour period. Clinical monitoring and blood sampling will occur in order to determine the safety profile of cocaethylene. During Part 3, the ability of cocaethylene to modify the acute effects of intravenous cocaine will be determined. Cocaethylene will be administered in plasma concentrations of 0 ng/ml, 50 ng/ml, or 200 ng/ml over an 8-hour period. Participants will be randomly assigned to receive a challenge intravenous dose of cocaine (0.5 mg/kg or 1 mg/kg) or placebo at the 4-hour mark of cocaethylene infusion. Following the initial 8-hour period, cocaethylene infusion will be continued for an additional 5 hours. Behavioral and physiological measures will be collected throughout the study sessions at predetermined times to evaluate whether tolerance to cocaethylene develops. These measures will also help to determine whether cocaethylene modifies or produces tolerance to the effects of an acute dose of cocaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Meets DSM-IV criteria for cocaine dependence
- Cocaine use of at least 0.5 grams each week during the three months prior to enrollment, confirmed by a positive urine test for cocaine metabolite
- Females are eligible if currently using adequate contraception, not planning to become pregnant, or surgically sterilized
- Females of child-bearing potential must have a negative pregnancy test prior to study entry
- Currently not physiologically dependent on alcohol, but may meet DSM-IV criteria for alcohol abuse or dependence
Key exclusion criteria (9 listed)
- Meets DSM-IV criteria for dependence on any drugs (other than nicotine or alcohol) within the year prior to enrollment
- Currently abuses other substances such as opiates, sedative-hypnotics, or amphetamines (excluding marijuana or nicotine) more than twice a week
- History of a serious medical illness or indication of a serious medical illness such as seizures, hypertension, heart disease, an abnormal ECG, anemia, diabetes, or abnormal blood flow sounds
- Meets DSM-IV criteria for a current major mental disorder, including major depression, bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or organic mental syndrome
- Currently being treated with psychotropic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocaethylene | Drug | – |
Primary outcome
Clinical physiological response to cocaine challenge - especially adverse effects measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elinore Mccance-Katz, M.D., Ph.D. principal investigator
Yale Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cocaethylene 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 5 inclusion and 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinical physiological response to cocaine challenge - especially adverse effects measures. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.