Smoking Clinical Trial
Official title:
Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4
Verified date | August 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain within and outside of laboratory settings in samples of smokers and overweight/obese individuals with binge eating disorder. This is the fourth phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.
Status | Completed |
Enrollment | 91 |
Est. completion date | August 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Understand English sufficiently to provide informed consent - Right-handed - Normal or corrected-to-normal vision and no color blindness - Interest in engaging with Laddr to modify self-regulatory behavior Additional Inclusion Criteria for Smoking sample: - Smoke 5 or more tobacco cigarettes/day for past year - BMI greater than or equal to 17 and less than 27 Additional Inclusion Criteria for Binge Eating Sample: - BMI greater than or equal to 27 and less than 45 - Weight limit of 350 lbs - Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers) Exclusion Criteria: - Significant medical illness - History of mental disorder due to a medical condition - Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder) - Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers) Additional Exclusion criteria for Binge Eating Sample: - Lost weight in recent past (>10 pounds in past 6 months) - Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig) - Currently on a special diet for a serious health condition - Current engagement in psychotherapy for binge eating disorder Additional Exclusion Criteria for Smoking Sample: - Binge eating behavior - Current engagement in psychotherapy for smoking behavior |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Center for Cognitive and Neurobiological Imaging | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Binge Eating Episodes - Loss of Control | Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 0 (No), 1 (Yes). Responses provided were averaged across the 28-day period. | 28 days | |
Primary | Binge Eating Episodes - Overeating | Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Overeating is assessed by the question "Since the last prompt, when you ate most recently, did you overeat?" and is scored as 0 (no) or 1 (yes). Responses provided were averaged across the 28-day period. | 28 days | |
Primary | Number of Cigarettes Smoked Per Day | Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A smoking episode is defined as self-reported smoking of more than zero cigarettes and is assessed by the question "Since the last prompt, how many cigarettes have you smoked?" Participants are asked to input a number into a number field and this was averaged over the 28 day period. | 28 days |
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