NCT00000297

Brief Summary

The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1998

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 1998

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 1998

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Subjective

  • Physiologic measures

Interventions

LabetalolDRUG

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male/Female, aged 21-55 years with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests.

You may not qualify if:

  • History of heart disease, peripheral vascular disease, COPD, any other medical condition which physician investigator deems inappropriate for subject participation. Pregnant or lactating or not using adequate birth control methods. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Gaoussou S, Attaher O, Swihart B, Traore M, Diarra S, Soumbounou IH, Ndiaye O, Issiaka D, Morrison R, Mahamar A, Duffy PE, Dicko A, Fried M. Pregnancy outcomes in a malaria-exposed Malian cohort of women of child-bearing age. Front Med (Lausanne). 2022 Dec 8;9:1061538. doi: 10.3389/fmed.2022.1061538. eCollection 2022.

    PMID: 36569122DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Labetalol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAmines

Study Officials

  • Dorothy Hatsukami, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

October 1, 1998

Study Completion

December 1, 2001

Last Updated

January 12, 2017

Record last verified: 1998-10

Locations

US(1)