Drug Discrimination in Methadone-Maintained Humans Study 2 (OMDD2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00733239
First received: August 11, 2008
Last updated: April 16, 2012
Last verified: April 2012

August 11, 2008
April 16, 2012
August 2008
October 2010   (final data collection date for primary outcome measure)
Drug Discrimination Performance [ Time Frame: Every Session ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00733239 on ClinicalTrials.gov Archive Site
  • Self-report Ratings [ Time Frame: Every Session ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: Every Session ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Test Sessions ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Drug Discrimination in Methadone-Maintained Humans Study 2
Drug Discrimination in Methadone-Maintained Humans Study 2

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)
Primary Purpose: Basic Science
Opioid Dependence
Drug: 2-4 of the drugs listed below
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given Diltiazem: 30, 60, 120 mg oral capsule may possibly be given Gabapentin: 100, 200, 400 mg oral capsule may possibly be given Isradipine: 5, 10 mg oral capsule may possibly be given Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given Nifedipine: 5, 10, 20 mg oral capsule may possibly be given Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given Saline: I.M. injection may possibly be given Verapamil: 30, 60, 120 mg oral capsule may possibly be given
Other Names:
  • Cycloserine: Calan, Veralan
  • Diltiazem: Cardizem
  • Gabapentin: Neurontin
  • Isradipine: DynaCirc
  • Naloxone: Narca
  • Nifedipine: Adalat, Procardia
  • Placebo
  • Saline
  • Verapamil: Veralan
Experimental: 1
Receives 2-4 of the drugs listed under Intervention
Intervention: Drug: 2-4 of the drugs listed below
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2010
October 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 month 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:

  1. Unstable medical condition or stable medical condition that would interact with study medications or participation.
  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 (< 1 week) use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested. Recent use will be defined based upon the pharmacokinetics of the drug and dosing schedule. Thus, a short-acting antihistamine taken as needed (e.g., once the night before) will not necessarily rule out a participant; however,
  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 (ALT, AST) greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
  8. ECG abnormalities including but not limited to: bradycardia (<60 bpm); 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
 
NCT00733239
R01-DA010017-02, R01DA010017-02, 104881, 5 R01 DA010017-02, DPMCDA
Yes
University of Arkansas
University of Arkansas
National Institute on Drug Abuse (NIDA)
Principal Investigator: Alison Oliveto, Ph.D. University of Arkansas
University of Arkansas
April 2012

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