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Early Tobacco Abstinence - 5

Early Tobacco Abstinence in High Risk Smokers

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00224965
Enrollment
140
Registered
2005-09-23
Start date
Unknown
Completion date
2004-10-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Keywords

nicotine dependence

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.

Interventions

BEHAVIORALBehavior Therapy

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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 -

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026