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Sleep Management for Nicotine Addiction
N/A
Recruiting
Led By Karen L Cropsey, Psy.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Daily smoker (5 or more cigarettes a day for the past one year and having smoked more than 100 cigarettes in lifetime) or non-smoker (smoked fewer than 100 cigarettes in a lifetime and no smoking-not even a puff- in the last year)
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the hypothesis that chronotype (preference for morning or evening activity) and impaired sleep impact cigarette usage, smoking dependence, urge/craving, and withdrawal differently in blacks compared to whites.
Who is the study for?
This trial is for adults over 18 who can read and speak English, identify as non-Hispanic African American or white, and live in Alabama. It's for daily smokers (5+ cigarettes a day for the past year) or non-smokers (less than 100 cigarettes lifetime, none in the last year).
What is being tested?
The study examines how sleep patterns affect cigarette cravings and withdrawal by comparing two conditions: extending participants' sleep time versus restricting it. The focus is on racial differences in these effects.
What are the potential side effects?
Since this trial involves manipulating sleep patterns, side effects may include tiredness, irritability, changes in mood or alertness due to altered sleep duration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a daily smoker or I have never smoked more than 100 cigarettes in my life.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sleep Hygiene Index
Secondary study objectives
Dysfunctional Beliefs and Attitudes About Sleep (DBAS)
Epworth Sleepiness Scale (ESS)
Everyday Discrimination Scale (EDS)
+6 moreOther study objectives
Alcohol Use Disorders Identification Test-Concise (AUDIT-C).
Assessing Smoking History
Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM-37)
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sleep RestrictionExperimental Treatment1 Intervention
4 hours time in bed (1 am to 5 am)
Group II: Sleep ExtensionExperimental Treatment1 Intervention
10 hours time in bed (10 pm to 8 am)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep restriction condition
2021
N/A
~140
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,765 Total Patients Enrolled
68 Trials studying Smoking
22,716 Patients Enrolled for Smoking
University of OklahomaOTHER
474 Previous Clinical Trials
93,641 Total Patients Enrolled
3 Trials studying Smoking
93 Patients Enrolled for Smoking
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,325 Total Patients Enrolled
Karen L Cropsey, Psy.D.Principal InvestigatorUniversity of Alabama at Birmingham
3 Previous Clinical Trials
749 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a daily smoker or I have never smoked more than 100 cigarettes in my life.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep Restriction
- Group 2: Sleep Extension
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Smoking Patient Testimony for trial: Trial Name: NCT03968900 — N/A