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Drug DependencePhase 1OMDD1NCT00593463

Drug Discrimination in Methadone-Maintained Humans Study 1

A Phase 1 study testing Cycloserine, Diltiazem and Gabapentin in people with Drug Dependence, run by University of Arkansas 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

This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Drug Dependence
What is being tested?
Cycloserine, Diltiazem and Gabapentin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Sep 2006to May 2010
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be between the ages of 18-65.
  • Participation in the UAMS Substance Abuse Treatment Clinic Methadone Maintenance Program or the CATAR Clinic Little Rock with maintenance on a stable dose of methadone (+ or - 10 mg) for at least 1 month prior to study entry.
  • Subjects would have to be in "good standing" in the methadone maintenance program in order to participate; i.e., compliance with scheduled medication and group therapy session hours. This would be defined as < 3 missed methadone medications and missed < 3 group or <3 individual therapy sessions in the two months prior to study participation
  • Subjects must submit a urine sample negative for illicit drugs prior to study entry.
  • Subjects must be able to read and understand English.

Who cannot join

  • Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined by history provided by the prospective subject or laboratory evaluation as outlined below).
  • Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
  • History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
  • Pregnancy, plans to become pregnant or inadequate birth control.
  • Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested.
  • History of severe reaction to Narcan challenge, which may have been given as part of admission into the Methadone Maintenance Program or to reverse overdose.
  • Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
  • EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged with QTc interval (>420 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.

Conditions
Drug Dependence
Being tested
Cycloserine, Diltiazem, Gabapentin, Isradipine, Naloxone
Keywords
opioid dependence, methadone, opioid
Medical subject headings
Substance-Related Disorders, Opioid-Related Disorders

What participants receive

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

  • CycloserineDrug

    Also called Calan, Veralan

    Cycloserine: 500, 675, 750 mg oral capsule may possibly be given

  • DiltiazemDrug

    Also called Cardizem

    Diltiazem: 30, 60, 120 mg oral capsule may possibly be

  • GabapentinDrug

    Also called Neurontin

    Gabapentin: 100, 200, 400 mg oral capsule may possibly be given

  • IsradipineDrug

    Also called DynaCirc

    Isradipine: 5, 10 mg oral capsule may possibly be given

  • NaloxoneDrug

    Also called Narca

    Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given

  • NifedipineDrug

    Also called Adalat, Procardia

    Nifedipine: 5, 10, 20 mg oral capsule may possibly be given

  • PlaceboDrug

    Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given

  • SalineDevice

    Saline: I.M. injection may possibly be given

  • VerapamilDrug

    Also called Veralan

    Verapamil: 30, 60, 120 mg oral capsule may possibly be given

Study groups in NCT00593463
Study groupRoleWhat they receive
1ExperimentalReceives 2-4 of the interventions listed
Receives: Drug: Cycloserine; Drug: Diltiazem; Drug: Gabapentin; Drug: Isradipine; Drug: Naloxone; Drug: Nifedipine; Drug: Placebo; Device: Saline; Drug: Verapamil

What is being measured

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

  1. Drug Discrimination Measure

    Measured: Every session

Secondary outcomes (2)

  1. Self-reported effects

    Measured: Every Session

  2. Vital Signs

    Measured: Every session

Timeline

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

  1. First posted15 Jan 2008 (estimated)
  2. Study startSep 2006
  3. Primary completionMay 2010
  4. Study completionMay 2010

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
Allocation
Not applicable
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00593463
Sponsor's protocol ID
R01DA010017-01
Other IDs
57184, R01DA010017, DPMC
Acronym
OMDD1
Status last verified
Mar 2011
First submitted
4 Jan 2008
Last updated
11 Mar 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cycloserine, Diltiazem and Gabapentin in people with Drug Dependence, run by University of Arkansas 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 8 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 11 Mar 2011. 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?

Drug Discrimination Measure (time frame: Every session). 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 NCT00593463.

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 11 Mar 2011.

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