NCT00616746

Brief Summary

The purpose of this study is to characterize the interactive effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2007

Typical duration for early_phase_1

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

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

3.4 years

First QC Date

February 4, 2008

Last Update Submit

July 7, 2014

Conditions

Alcohol ConsumptionTobacco Use

Keywords

Alcohol, nicotine

Outcome Measures

Primary Outcomes (1)

  • Behavioral and Cognitive Measures

    Baseline and Test Day

Study Arms (1)

1

EXPERIMENTAL

Three test days, within-subject design.

Drug: NicotineDrug: Ethanol

Interventions

NicotineDRUG

1.0 microg/kg/min IV x 10 minutes

1
EthanolDRUG

IV

1

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or Female, 21 to 50 years old.

You may not qualify if:

  • Alcohol or Nicotine Naive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System, West Haven Campus

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingTobacco Use

Interventions

NicotineEthanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingAlcoholsOrganic Chemicals

Study Officials

  • Deepak C D'Souza, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

January 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

US(1)