AzTrials
AzTrials

Cocaine-Related DisordersPhase 1NCT00015067

Cocaine-Methylphendidate Interaction Study - 4

A Phase 1 study testing Methylphenidate 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
Search all trials

Trial summary

The purpose of this study is to attempt to identify possible dangerous interactions between cocaine and methylphenidate (MPD). Additional objectives are to determine: a) if MPD reduces the craving and high for cocaine; b) if there are pharmacokinetic and pharmacodynamic interactions between cocaine and MPD; and c) the… Read more about this study

Who is it for?
Ages 21 to 45 years
Conditions the study is for
Cocaine-Related Disorders
What is being tested?
Methylphenidate
How many people
8 participants
Where
1 siteUnited States
Study dates
Dec 1997to not given
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 21 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • male or female of any race, between 21 and 45 years of age.
  • cocaine dependent according to DSM-IV criteria.
  • currently use cocaine by smoked or intravenous route of administration and confirmed by positive urine screen for benzoylecgonine within 2 weeks prior to signing the informed consent form. The subjects who currently use cocaine by smoked route must have a history of intravenous exposure to drugs of abuse.
  • in stable physical and mental health as judged by interview and physical examinations.
  • for female subjects, test non-pregnant and use adequate birth control. All female subjects will have a serum pregnancy test performed prior to the first dose of study medication.
  • be capable of providing written informed consent to participate in this study.
  • able to comply with protocol requirements and be likely to complete all study treatments.
  • within 20% of ideal body weight.

Who cannot join

  • require detoxification from alcohol, opiates, or sedative-hypnotics.
  • have a history of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematological or metabolic disorders.
  • have a history of adverse reaction to cocaine including loss of consciousness, chest pain, psychosis, or seizure.
  • have a history of adverse reaction/hypersensitivity to methylphenidate.
  • test positive upon urine toxicology screen for opiates, benzodiazepines, barbiturates or related CNS depressants, amphetamines or related stimulants.
  • have clinically significant abnormal laboratory measurements in liver function tests (AST and ALT levels greater than 3 times of the upper limit of normal), hematology (CBC, differential, platelet count), serum chemistries (SMA-24) and EKG.
Show all 14Show fewer
  • have any significant active medical, or psychiatric illness which might inhibit their ability to complete the study or might be complicated by administration of the test drug.
  • have active hypertension as defined by the American Heart Association criteria.
  • currently receive any medications for the treatment of any significant medical conditions.
  • have a history of glaucoma.
  • have a diagnosis or family history of Tourettes syndrome.
  • have an abnormal thyroid function (as determined by an abnormal T4 level).
  • have a history of seizures or seizure disorder.
  • have any medical history or condition considered by the investigator(s) to place the subjects at increased risk.

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: Cocaine-Methylphendidate Interaction Study

The purpose of this study is to attempt to identify possible dangerous interactions between cocaine and methylphenidate (MPD). Additional objectives are to determine: a) if MPD reduces the craving and high for cocaine; b) if there are pharmacokinetic and pharmacodynamic interactions between cocaine and MPD; and c) the relationship between cocaine and benzoylecgonine (BE) levels in plasma and BE levels in urine.

Read the detailed description

This study was conducted to evaluate the cardiovascular risk of prescribing up to 90 mg of methylphenidate (MPD) daily for treating cocaine dependence. This within-subject study was completed in an inpatient setting. It was non-blinded for MPD dose and single-blinded for cocaine dose. Each patient was given intravenous cocaine at 0, 20 and 40 mg while at three different steady state levels of MPD (0, 60 and 90 mg). Seven non-treatment seeking cocaine addicts, who were recruited from the community, completed the study. There were no cardiac rhythm abnormalities noted except for sinus tachycardia and sinus bradycardia. There were no incidences of seizures or myocardial ischemia. In a repeated measures ANOVA, MPD was shown to have an independent positive effect on heart rate (p=0.0001) but not on SBP or DBP. There was no cocaine by MPD interaction for any vital sign. Peak systolic blood pressure (SBP) and diastolic blood pressure (DBP) for any patient up to 60 minutes after infusion was 169 mm and 108 mm, respectively. The first occurred when 60 mg of MPD and placebo cocaine were given and the second when no MPD and placebo cocaine were given. Peak heart rate for any patient up to 60 min after infusion was 143/min at 60 mg of MPD and 40mg of cocaine. The number of adverse events reported when cocaine and MPD were given together was less than the number reported when either drug was given alone. The adverse events reported when cocaine and MPD were given together included headache, nervousness, and lightheadedness. Subjective ratings of drug effect revealed that MPD did not enhance patients' response to, or desire for, cocaine. MPD appears to be a safe drug to use in cocaine addicts who continue to use cocaine at the dosages tested.

Being tested
Methylphenidate
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 withdrawal

  2. Hemodynamic response to cocaine before and after MPD administrtation

  3. Cocaine related high

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 startDec 1997

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 1
Primary purpose
Treatment
Intervention model
Crossover
Enrolment
8 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015067
Sponsor's protocol ID
NIDA-5-0012-4
Other IDs
Y01-5-0012-4
Status last verified
Oct 1998
First submitted
18 Apr 2001
Last updated
12 Jan 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Methylphenidate 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 8 inclusion and 14 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?

Cocaine withdrawal. 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 NCT00015067.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in