Clinical trial NCT00224965: Early Tobacco Abstinence - 5
Official title: Early Tobacco Abstinence in High Risk Smokers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tobacco Use
Keywords: nicotine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-09-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Yale University, Dept. of Psychiatry
state: Minnesota
Study officials:
affiliation: Substance Abuse Treatment Unit
name: Stephanie O'Malley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: