Clinical Trials Logo

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
Est. primary completion date
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


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, 

See also
  Status Clinical Trial Phase
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Recruiting NCT06033599 - Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement Phase 3
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT06105424 - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability N/A
Completed NCT01311830 - Enhancing Smoker Utilization of the Minnesota Quitline Through Support Persons N/A
Completed NCT04566198 - Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)
Completed NCT04107779 - Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS N/A
Completed NCT05092919 - The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults Early Phase 1
Terminated NCT05274217 - Journey of Transformation Curriculum for Native American Adolescents N/A
Enrolling by invitation NCT06042361 - Enhancing Equity in Smoke-free Housing N/A
Completed NCT03235713 - EMA for Tobacco Control Policy Research
Withdrawn NCT03352635 - Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core N/A
Completed NCT03151421 - Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home N/A
Completed NCT03446170 - Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers N/A
Completed NCT04104152 - CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting N/A
Not yet recruiting NCT05999383 - Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration Phase 2
Recruiting NCT04429568 - THC Crossover Study N/A
Completed NCT04632030 - Shrinking the Size of the Tobacco Power Wall N/A
Completed NCT04143256 - Evaluating Selected Constituents in the Exhaled Breath Samples N/A