Early Tobacco Abstinence - 5

NCT ID: NCT00224965

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2004-10-31

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.

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.

Conditions

Tobacco Use

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Behavior Therapy

Intervention Type: BEHAVIORAL

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Principal Investigators

Stephanie O'Malley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Substance Abuse Treatment Unit

Locations

Yale University, Dept. of Psychiatry

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

P50-13334-5

Identifier Type: -

Identifier Source: secondary_id

NIDA-13334-5

Identifier Type: -

Identifier Source: org_study_id