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
Information provided by:
National Institute on Drug Abuse (NIDA)
First received: September 22, 2005
Last updated: November 3, 2005
Last verified: September 2005
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.
Behavioral: Behavior Therapy
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Early Tobacco Abstinence in High Risk Smokers
| Estimated Enrollment:
| Estimated Study Completion Date:
- 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,
- 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.
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- Current dependence on cocaine, marijuana, opiates or alcohol
- Positive urine screen for marijuana, cocaine or opiates at any appointment after the intake appointment.
- Regular use of any psychoactive drugs including anxiolytics and antidepressants;
- Current major depression or other psychiatric conditions
- 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 -
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224965
|Yale University, Dept. of Psychiatry
|Minneapolis, Minnesota, United States, 55415 |
||Stephanie O'Malley, Ph.D.
||Substance Abuse Treatment Unit
No publications provided
ClinicalTrials.gov processed this record on December 11, 2013
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 22, 2005
||November 3, 2005
||United States: Federal Government