Early Tobacco Abstinence - 5

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00224965
First received: September 22, 2005
Last updated: November 3, 2005
Last verified: September 2005
  Purpose

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.


Intervention Phase
Behavioral: Behavior Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Tobacco Abstinence in High Risk Smokers

Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment: 140
Estimated Study Completion Date: October 2004
Detailed Description:
  1. To compare male and female smokers, with and without current depressive symptoms, in a prospective study of the intensity, content & duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence and,
  2. To compare male and female smokers, who are either heavy alcohol drinkers or light alcohol drinkers, in a prospective study of the intensity, content & duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) 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

Exclusion Criteria:

  1. Current dependence on cocaine, marijuana, opiates or alcohol
  2. Positive urine screen for marijuana, cocaine or opiates at any appointment after the intake appointment.
  3. Regular use of any psychoactive drugs including anxiolytics and antidepressants;
  4. Current major depression or other psychiatric conditions
  5. 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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224965

Locations
United States, Minnesota
Yale University, Dept. of Psychiatry
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Investigators
Principal Investigator: Stephanie O'Malley, Ph.D. Substance Abuse Treatment Unit
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00224965     History of Changes
Other Study ID Numbers: NIDA-13334-5, P50-13334-5
Study First Received: September 22, 2005
Last Updated: November 3, 2005
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 23, 2014