Cognition and Smoking Relapse (HCS)
NCT03169101, Completed, University of Pennsylvania; results first posted 2024-05-10
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognition and Smoking Relapse (HCS) | ClinicalTrials.gov |
| NCT number | NCT03169101 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 274 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Pennsylvania | ClinicalTrials.gov |
| Conditions | Smoking Cessation | ClinicalTrials.gov |
| Interventions | Nicotine patch, Behavioral counseling | ClinicalTrials.gov |
| First posted | 2017-05-30 | ClinicalTrials.gov |
| Last updated | 2024-05-10 | ClinicalTrials.gov |
| Results first posted | 2024-05-10 | ClinicalTrials.gov |
Registered outcomes 2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cognitive Function | Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12) | Cognitive function will be assessed at the Lab session 1 and lab session 2 visits as well as End of Treatment. Participants will complete measures of executive function, verbal learning and memory and response inhibition. The primary outcome is the change in cognitive function lab session 1, lab session 2, and End of Treatment measured by a composite score (calculated by averaging individual z-scores). Z-scores were calculated using the Stroop interference score (executive function; measured in milliseconds), the delayed recall score from the Hopkins Verbal Learning Test (verbal learning and memory), and the Stop signal reaction time from the Stop Signal Task (response inhibition, measured in milliseconds). A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance. | ClinicalTrials.gov |
| Secondary | 7-day Point Prevalence Abstinence | End of Treatment (week 12) | Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 12). The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by carbon monoxide \< 5 ppm. | ClinicalTrials.gov |
Outcomes 2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Cognitive Function | Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12) | Numbers are different due to attrition between enrollment and lab session 1. Some cognitive data were excluded due to outliers. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | 7-day Point Prevalence Abstinence | End of Treatment (week 12) | Only subjects who entered treatment following the two lab sessions were considered intent to treat and included in this analysis. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
Results by group 14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Cognitive Function | HIV+ Smoking Lab Session First | Lab session 1 (week 1) | 0.125 | Standard Deviation 0.489 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV- Smoking Lab Session First | Lab session 1 (week 1) | -.093 | Standard Deviation 0.441 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV+ Abstinent Lab Session First | Lab session 1 (week 1) | -.059 | Standard Deviation .452 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV- Abstinent Lab Session First | Lab session 1 (week 1) | -.008 | Standard Deviation .553 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV+ Smoking Lab Session First | Lab session 2 (week 2) | .043 | Standard Deviation .498 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV- Smoking Lab Session First | Lab session 2 (week 2) | -.012 | Standard Deviation .441 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV+ Abstinent Lab Session First | Lab session 2 (week 2) | -.106 | Standard Deviation .488 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV- Abstinent Lab Session First | Lab session 2 (week 2) | .014 | Standard Deviation .546 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV+ Smoking Lab Session First | End of treatment (week 12) | 0.149 | Standard Deviation .416 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV- Smoking Lab Session First | End of treatment (week 12) | -.082 | Standard Deviation .465 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV+ Abstinent Lab Session First | End of treatment (week 12) | -.091 | Standard Deviation .440 | z-score | ClinicalTrials.gov |
| Cognitive Function | HIV- Abstinent Lab Session First | End of treatment (week 12) | .001 | Standard Deviation .559 | z-score | ClinicalTrials.gov |
| 7-day Point Prevalence Abstinence | HIV+ | 22 | Participants | ClinicalTrials.gov | ||
| 7-day Point Prevalence Abstinence | HIV- | 33 | Participants | ClinicalTrials.gov |
Participant flow 36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Lab Session 1 (Week 1) | STARTED | HIV+, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 41 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | STARTED | HIV-, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 77 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | STARTED | HIV+, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 43 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | STARTED | HIV-, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 80 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | COMPLETED | HIV+, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 41 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | COMPLETED | HIV-, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 77 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | COMPLETED | HIV+, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 43 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | COMPLETED | HIV-, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 76 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | NOT COMPLETED | HIV+, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 0 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | NOT COMPLETED | HIV-, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 0 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | NOT COMPLETED | HIV+, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 0 | ClinicalTrials.gov | |
| Lab Session 1 (Week 1) | NOT COMPLETED | HIV-, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 4 | ClinicalTrials.gov | |
| Lab Session 2 (Week 2) | STARTED | HIV+, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 41 | ClinicalTrials.gov | |
| Lab Session 2 (Week 2) | STARTED | HIV-, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 77 | ClinicalTrials.gov | |
| Lab Session 2 (Week 2) | STARTED | HIV+, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 43 | ClinicalTrials.gov | |
| Lab Session 2 (Week 2) | STARTED | HIV-, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 76 | ClinicalTrials.gov | |
| Lab Session 2 (Week 2) | COMPLETED | HIV+, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 39 | ClinicalTrials.gov | |
| Lab Session 2 (Week 2) | COMPLETED | HIV-, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment | 60 | ClinicalTrials.gov | |
| Lab Session 2 (Week 2) | COMPLETED | HIV+, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 41 | ClinicalTrials.gov | |
| Lab Session 2 (Week 2) | COMPLETED | HIV-, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment | 70 | ClinicalTrials.gov |
Adverse events 16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Difficulty breathing | Respiratory, thoracic and mediastinal disorders | HIV+ | 10 | 80 | 24 | ClinicalTrials.gov |
| other | Difficulty breathing | Respiratory, thoracic and mediastinal disorders | HIV- | 6 | 127 | 31 | ClinicalTrials.gov |
| other | Itching, burning or tingling at patch site | Skin and subcutaneous tissue disorders | HIV+ | 6 | 80 | 12 | ClinicalTrials.gov |
| other | Itching, burning or tingling at patch site | Skin and subcutaneous tissue disorders | HIV- | 7 | 127 | 8 | ClinicalTrials.gov |
| other | Skin redness | Skin and subcutaneous tissue disorders | HIV+ | 9 | 80 | 16 | ClinicalTrials.gov |
| other | Skin redness | Skin and subcutaneous tissue disorders | HIV- | 2 | 127 | 3 | ClinicalTrials.gov |
| other | Sleep disturbances | General disorders | HIV+ | 13 | 80 | 32 | ClinicalTrials.gov |
| other | Sleep disturbances | General disorders | HIV- | 24 | 127 | 48 | ClinicalTrials.gov |
| other | Vivid dreams | General disorders | HIV+ | 9 | 80 | 13 | ClinicalTrials.gov |
| other | Vivid dreams | General disorders | HIV- | 13 | 127 | 25 | ClinicalTrials.gov |
| other | Weakness | General disorders | HIV+ | 6 | 80 | 7 | ClinicalTrials.gov |
| other | Weakness | General disorders | HIV- | 8 | 127 | 8 | ClinicalTrials.gov |
| serious | Stroke | Cardiac disorders | HIV+ | 0 | 80 | 0 | ClinicalTrials.gov |
| serious | Stroke | Cardiac disorders | HIV- | 1 | 127 | 1 | ClinicalTrials.gov |
| serious | Sciatica | Nervous system disorders | HIV+ | 0 | 80 | 0 | ClinicalTrials.gov |
| serious | Sciatica | Nervous system disorders | HIV- | 1 | 127 | 1 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | HIV+ | 0 | 80 | ClinicalTrials.gov |
| Total, all-cause mortality | HIV- | 0 | 127 | ClinicalTrials.gov |
| Total, other adverse events | HIV+ | 32 | 80 | ClinicalTrials.gov |
| Total, other adverse events | HIV- | 36 | 127 | ClinicalTrials.gov |
| Total, serious adverse events | HIV+ | 0 | 80 | ClinicalTrials.gov |
| Total, serious adverse events | HIV- | 2 | 127 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40471817 | DERIVED | PubMed |
Trial comparisons 3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HIV+ vs HIV-: deaths from any cause | Trial comparisons |
| HIV+ vs HIV-: 7-day Point Prevalence Abstinence | Trial comparisons |
| HIV+ vs HIV-: serious adverse events | Trial comparisons |
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stop-Signal Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.