Health TrialsbyHealthPanel

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

ConditionsTobacco UseTobacco CessationInsomnia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English literate

report heavy tobacco use (including nicotine e-cigarettes) for >6 months

meet biochemical cut off for recent cigarette smoking or e-cigarette use

optimal body mass index

Disqualifiers

currently enrolled in other treatments

neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and/or induce deficient sleep

medical contraindications for fMRI, varenicline, and/or behavioral treatment

factors that cause deficient sleep and for which behavioral treatment has less benefit

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental health intervention

    Behavioral

    Behavioral health intervention

  • Varenicline

    Drug

    Days 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Experimental health interventionExperimental treatment 2 interventions
Group B: Control health interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean number cigarettes smoked per day

Mean number cigarettes smoked per day assessed by Time Line Follow Back method

Time frame
Baseline, week 4, 8, 12, and 26
2

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).

Time frame
Baseline
3

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)

Time frame
Week 4, 8, 12, and 26
4

Days to smoking relapse

Days of resuming smoking since Week 4 schedule quit date as assessed by the Time Line Follow-back

Time frame
Week 4, 8, 12, and 26

Secondary outcomes

1

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.

Time frame
Baseline, week 4, 8, 12, and 26
2

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.

Time frame
Baseline, week 4, 8, 12, and 26
3

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.

Time frame
Baseline, week 4, 8, 12, and 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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