Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Drug Discrimination in Methadone-Maintained Humans Study 1 (OMDD1)

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00593463
First received: January 4, 2008
Last updated: March 10, 2011
Last verified: March 2011

January 4, 2008
March 10, 2011
September 2006
May 2010   (final data collection date for primary outcome measure)
Drug Discrimination Measure [ Time Frame: Every session ] [ Designated as safety issue: No ]
Drug Discrimination Measure [ Time Frame: 3-5 times/week for duration of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00593463 on ClinicalTrials.gov Archive Site
  • Self-reported effects [ Time Frame: Every Session ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: Every session ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Drug Discrimination in Methadone-Maintained Humans Study 1
Drug Discrimination in Methadone-Maintained Humans Study 1

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Drug Dependence
  • Drug: Cycloserine
    Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
    Other Names:
    • Calan
    • Veralan
  • Drug: Diltiazem
    Diltiazem: 30, 60, 120 mg oral capsule may possibly be
    Other Name: Cardizem
  • Drug: Gabapentin
    Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
    Other Name: Neurontin
  • Drug: Isradipine
    Isradipine: 5, 10 mg oral capsule may possibly be given
    Other Name: DynaCirc
  • Drug: Naloxone
    Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
    Other Name: Narca
  • Drug: Nifedipine
    Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
    Other Names:
    • Adalat
    • Procardia
  • Drug: Placebo
    Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given
  • Device: Saline
    Saline: I.M. injection may possibly be given
  • Drug: Verapamil
    Verapamil: 30, 60, 120 mg oral capsule may possibly be given
    Other Name: Veralan
Experimental: 1
Receives 2-4 of the interventions listed
Interventions:
  • Drug: Cycloserine
  • Drug: Diltiazem
  • Drug: Gabapentin
  • Drug: Isradipine
  • Drug: Naloxone
  • Drug: Nifedipine
  • Drug: Placebo
  • Device: Saline
  • Drug: Verapamil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Must be between the ages of 18-65.
  2. 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.
  3. 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
  4. Subjects must submit a urine sample negative for illicit drugs prior to study entry.
  5. Subjects must be able to read and understand English.

Exclusion Criteria:

Exclusion criteria

  1. Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined by history provided by the prospective subject or laboratory evaluation as outlined below).
  2. Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
  3. History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
  4. Pregnancy, plans to become pregnant or inadequate birth control.
  5. 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.
  6. 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.
  7. Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
  8. 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00593463
R01-DA010017-01, 57184, R01DA010017, DPMC
Yes
Alison Oliveto, Ph.D./Principal Investigator, University of Arkansas for Medical Sciences
University of Arkansas
Not Provided
Principal Investigator: Alison Oliveto, PhD University of Arkansas
University of Arkansas
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP