Early Tobacco Abstinence - 5

Tobacco Use Clinical Trial

Official title:

Early Tobacco Abstinence in High Risk Smokers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00224965
• Other study ID #: NIDA-13334-5
• Secondary ID: P50-13334-5
• Status: Terminated
• Phase: Phase 1
• First received: September 22, 2005
• Last updated: January 11, 2017
• Est. completion date: October 2004

Study information

• Verified date: September 2005
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 -

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• Behavior Therapy

Locations

Country	Name	City	State
United States	Yale University, Dept. of Psychiatry	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States,