Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA061285 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.
The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms. The secondary objective of this study is to examine sex differences.
Investigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient Tobacco Treatment Service (TTS) at Yale-New Haven Hospital.
All participants will be assigned to one of two behavioral interventions. Both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring.
Participants will have a total of five expected research visits with a scheduled target quit date for Week 4. Participants will undergo MRI at baseline and at Week 4, and attend follow-ups at week 8, 12, and 26.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental health intervention | Experimental | Experimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks |
|
| Control health intervention | Active Comparator | Control health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental health intervention | Behavioral | Behavioral health intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean number cigarettes smoked per day | Mean number cigarettes smoked per day assessed by Time Line Follow Back method | Baseline, week 4, 8, 12, and 26 |
| Smoking status | Assess expired breath carbon monoxide (CO) at baseline. CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO <5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels). | Baseline |
| Quit status | To inquire whether participants have refrained from tobacco use at each visit following their quit date. The quit status will also be verified by assessing expired breath carbon monoxide (CO). CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO <5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels) | Week 4, 8, 12, and 26 |
| Days to smoking relapse | Days of resuming smoking since Week 4 schedule quit date as assessed by the Time Line Follow-back | Week 4, 8, 12, and 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PROMIS Sleep Disturbance | The PROMIS Sleep Disturbance is an 8 item self-report of perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each item on the measure is rated on a 5-point scale. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. High scores mean greater severity of sleep disturbance. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Chen, PhD | Contact | 347-819-2969 | yu.chen.yc838@yale.edu | |
| Lisa Fucito, PhD | Contact | 203-200-1470 | lisa.fucito@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chiang-Shan Li | Yale University | Principal Investigator |
| Lisa Fucito, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | Recruiting | New Haven | Connecticut | 06519 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D020340 | Tobacco Use Cessation |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Participants who smoke randomly assigned and stratified by sex and severity of tobacco dependence
Not provided
Not provided
Not provided
Not provided
| Varenicline | Drug | Days 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily. |
|
| Baseline, week 4, 8, 12, and 26 |
| Change in PROMIS Sleep-Related Impairment | The PROMIS Sleep-Related Impairment is an 8 item self-report of perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness. Each item on the measure is rated on a 4-point scale. The score range is 4 to 32. High scores mean greater severity of sleep related impairment. | Baseline, week 4, 8, 12, and 26 |
| Change in Insomnia Severity Index | The Insomnia Severity Index is a 7-item brief screening tool for insomnia. Each item on the measure is rated on a 5-point scale (0-4), with a total score range 0-28. High scores mean greater severity of insomnia. | Baseline, week 4, 8, 12, and 26 |
| Yale University | Recruiting | New Haven | Connecticut | 06520 | United States |
|
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D011810 | Quinoxalines |