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Completed

NCT Number: NCT01068847

Drug Discrimination in Methadone-Maintained Humans Study 3

This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the participant'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 participant will receive 2-4 of the listed interventions.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 and <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.

Exclusion criteria

  • Unstable medical condition (e.g., major, unstable cardiovascular, renal, endocrine or hepatic disease) or stable medical condition requiring treatment that would interact with study medications (e.g., controlled hypertension on an antihypertensive) or ability to participate in study sessions, (e.g.,chronic back pain that would preclude being able to sit for long periods, etc), to be determined by history provided by the prospective subject or laboratory evaluation and physical examination as outlined below. These would be determined by the study physician alone or in consultation with the PI.
  • Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
  • History of major psychiatric disorder (psychosis, schizophrenia, bipolar) or current psychiatric disorder that requires medication (e.g., current major depression).
  • Pregnancy, plans to become pregnant or inadequate birth control (adequate birth control includes an IUD, condoms, birth control pills, etc). Male participants are encouraged to use condoms because little has been studied on the effects of these drugs on the male reproductive system.
  • Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug (antidepressants, anxiolytics, antipsychotics and anticonvulsants that may also be used for mood stabilization or sleep disruption) or drug (e.g., ciprofloxacin, fluvoxamine) that would have major interaction with drugs to be tested.
  • Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
  • A supine or semi-recumbent blood pressure of 100/65mmHg, a seated blood pressure of 90/60mmHg, or orthostatic change of >20mmHg systolic or >10mmHg diastolic on standing or heart rate less than 60 beats/min.
  • EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 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.
  • Participants who become arrested and/or incarcerated will not be allowed to continue to participate.

Treatment and study plan

2-4 of the drugs listed below

Drug

Cycloserine: 500, 675, 750 mg oral capsules may possibly given. Naloxone: 0.15mg/70Kg or 0.2mg/70kg I.M. injection may possibly be given. Nifedipine: 10, 20 mg oral capsules may possibly be given. Placebo (sugar pill or microcrystalline cellulose): oral capsules may be given. Saline: I.M. injection may possibly be given. Tizanidine: 4, 8, 12 mg oral capsules may possibly be given. Verapamil: 30, 60, 120 mg oral capsules may possibly be given.

Other names: Cycloserine: Seromycin, Naloxone: Narcan, Nifedipine: Adalat, Procardia, Placebo, Saline, Tizanidine: Zanaflex, Verapamil: Veralan

Primary outcomes

  1. Drug Discrimination Performance

    Time frame: Every Session

Secondary outcomes

  1. Self-Report Ratings

    Time frame: Every Session

  2. Vital Signs

    Time frame: Every session

  3. ECG

    Time frame: Test Sessions

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: OMDD3

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2010
Registry last updated
Mar 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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