NCT00100074

Brief Summary

To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.

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
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

January 11, 2017

Status Verified

December 1, 2004

First QC Date

December 22, 2004

Last Update Submit

January 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Safety

Interventions

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals with a body mass index between 18 and 30.
  • Willing and able to give written consent.
  • Must have a negative drug test
  • Females must have a negative pregnancy test prior to study drug administration
  • Must have no medical contraindications as determined by routine testing

You may not qualify if:

  • Please contact the site for more information

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

Lobeline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Reese Jones, M.D.

    Langley Porter Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
DIAGNOSTIC
Sponsor Type
NIH

Study Record Dates

First Submitted

December 22, 2004

First Posted

December 23, 2004

Study Start

September 1, 2004

Study Completion

April 1, 2005

Last Updated

January 11, 2017

Record last verified: 2004-12

Locations