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 because the information has not been verified recently.
Verified December 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was Active, not recruiting
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
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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 |
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 |
| 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
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
Investigators
| Principal Investigator: | Reese Jones, M.D. | Langley Porter Psychiatric Institute |
More Information
No publications provided
| 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 Mental Disorders Methamphetamine Amphetamine Reserpine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Antihypertensive Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013