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A Phase 1 Parallel-Group, Double-Blind, Placebo-Controlled Cardiovascular and Behavioral Study Assessing Interactions Between Single Doses of Oral Reserpine and Intravenous Methamphetamine - 1

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00267657
First received: December 20, 2005
Last updated: October 25, 2007
Last verified: December 2005
  Purpose
In this parallel group clinical pharmacology laboratory experiment, we will assess pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.

Condition Intervention Phase
Amphetamine-Related Disorders
Drug: Reserpine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Assessment of Interactions Between IV Methamphetamine and Reserpine

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Craving
  • Cardiovascular
  • Subjective symptoms/Mood Effects
  • CNS norepinephrine turnover

Estimated Enrollment: 30
Study Start Date: January 2004
Estimated Study Completion Date: November 2004
Detailed Description:
In this parallel group clinical pharmacology laboratory experiment, we will assess pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.
  Eligibility

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Please contact site for more details

Exclusion Criteria:

  • Please contact site for more details
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267657

Locations
United States, California
U of CA, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Reese Jones, M.D. Langley Porter Psychiatric Institute
  More Information

ClinicalTrials.gov Identifier: NCT00267657     History of Changes
Other Study ID Numbers: NIDA-CPU-0006-1 
Study First Received: December 20, 2005
Last Updated: October 25, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
Reserpine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Antihypertensive Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on December 09, 2016