NCT00267657

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
Last Updated

January 11, 2017

Status Verified

December 1, 2005

First QC Date

December 20, 2005

Last Update Submit

January 10, 2017

Conditions

Amphetamine-Related Disorders

Outcome Measures

Primary Outcomes (4)

  • Craving

  • Cardiovascular

  • Subjective symptoms/Mood Effects

  • CNS norepinephrine turnover

Interventions

ReserpineDRUG

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Please contact site for more details

You may not qualify if:

  • Please contact site for more details

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U of CA, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

Reserpine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

YohimbineSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Reese Jones, M.D.

    Langley Porter Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

January 1, 2004

Study Completion

November 1, 2004

Last Updated

January 11, 2017

Record last verified: 2005-12

Locations

US(1)