NCT00224965

Brief Summary

This proposal will conduct a prospective examination of the clinical course (intensity, content and duration) of tobacco (nicotine) abstinence effects in male and female smokers who are either heavy/light alcohol drinkers with/without depressive symptoms.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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 Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

January 12, 2017

Status Verified

September 1, 2005

First QC Date

September 22, 2005

Last Update Submit

January 11, 2017

Conditions

Tobacco Use

Keywords

nicotine dependence

Interventions

Behavior TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) between ages 18-60 years; (2) able to read and write English (3) SMOKER: Smoking \>10 cigarettes per day for at least 1 year, with CO \> 10 ppm, and blood cotinine concentration of 150 ng/ml or greater, FTND scores \> 5.
  • (4) DEPRESSED SUBJECT: Not meeting SCID criteria for current major depression or more than one past major depressive episode, but having scores \> 10 on the CES-D indicating presence of depressive symptomatology (5) NON-DEPRESSED SUBJECT: Not meeting SCID criteria for current major depression or more than one past major depressive episode, CES-D scores \<10.
  • (6) HEAVY DRINKER: Not meeting SCID criteria for current alcohol dependence; drinking 20 or more drinks per month.
  • (7) LIGHT DRINKER: Not meeting SCID criteria for current alcohol dependence; drinking ten drinks or less per month

You may not qualify if:

  • Current dependence on cocaine, marijuana, opiates or alcohol
  • Positive urine screen for marijuana, cocaine or opiates at any appointment after the intake appointment.
  • Regular use of any psychoactive drugs including anxiolytics and antidepressants;
  • Current major depression or other psychiatric conditions
  • Subjects with any significant, untreated current medical conditions condition such as neurological, endocrine, cardiovascular, renal, liver, thyroid pathology or on medications for any recent medical events 6) Pregnant or lactating women -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University, Dept. of Psychiatry

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Tobacco UseTobacco Use Disorder

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Stephanie O'Malley, Ph.D.

    Substance Abuse Treatment Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 23, 2005

Study Completion

October 1, 2004

Last Updated

January 12, 2017

Record last verified: 2005-09

Locations

US(1)