Trial · NCT02432066
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 66
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8 | Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 | Nicotine use will be assessed using Timeline Followback procedures. Nicotine use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants. |
| Primary | Change in Carbon Monoxide (CO) from baseline at weeks 5, 8 | Change in baseline at Week 5, Week 8 | Expired Carbon Monoxide levels will be quantified in parts per million. |
| Primary | Change in Urine Cotinine (COT) from baseline at weeks 5, 8 | Change in baseline at Week 5, Week 8 | Cotinine excreted in urine will be quantified in ng/mL |
| Secondary | Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8 | Change in baseline at Week 5, Week 8 | The Beck Depression Inventory will be used to quantify depressive symptomatology. The measure is a 21-item, self-report, multiple-choice inventory, with scores ranging from 0-63. |
| Secondary | Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8 | Change in baseline at Week 5, Week 8 | The State Anxiety Inventory will be used to quantify anxiety symptomatology. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80. |
| Secondary | Change in State Anger (ANG-S) from baseline at weeks 5, 8 | Change in baseline at Week 5, Week 8 | The Spielberger State Anger Inventory will be used to assess state anger. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80. |
| Secondary | Pill Count - Week 1 | Week 1 | Medication compliance will be assessed with pill counts. |
| Secondary | Pill Count - Week 5 | Week 5 | Medication compliance will be assessed with pill counts. |
| Secondary | Pill Count - Week 8 | Week 8 | Medication compliance will be assessed with pill counts. |
| Secondary | Change in Minnesota Withdrawal Scale from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8 | Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 | The Minnesota Withdrawal Scale measures self-reported severity of nicotine withdrawal. The measure has 15 items, with five possible responses (0-5), thus scores on the scale range from 0 to 60. |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 1 | Week 1 | The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale. |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 2 | Week 2 | The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale. |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 3 | Week 3 | The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale. |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 4 | Week 4 | The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale. |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 5 | Week 5 | The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale. |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 6 | Week 6 | The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale. |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 7 | Week 7 | The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale. |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 8 | Week 8 | The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale. |
| Secondary | Change in Profile of Mood States 2-A from Baseline at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 | The Profile of Mood States-2 (short-form for adults) The POMS 2 is a multi-dimensional, assessment of transient moods, and states of affect. The measure includes 35 items, each rated on a 5-point scale (0-4). |
| Secondary | Rapid Visual Information Processing task (Behavior) - Baseline | Baseline | The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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