Trial Outcomes & Findings for Cognition and Smoking Relapse (HCS) (NCT NCT03169101)
NCT ID: NCT03169101
Last Updated: 2024-05-10
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
274 participants
Primary outcome timeframe
Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12)
Results posted on
2024-05-10
Participant Flow
Participant milestones
| Measure |
HIV+, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Participants were randomized to complete a smoking-as-usual lab session first followed by a 24-hour abstinence lab session second. All participants then received treatment.
Treatment:
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV-, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Participants were randomized to complete a smoking-as-usual lab session first followed by a 24-hour abstinence lab session second. All participants then received treatment.
Treatment:
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV+, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Participants were randomized to complete a 24-hour abstinence lab session first, followed by a smoking-as-usual lab session second. All participants then received treatment.
Treatment:
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV-, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Participants were randomized to complete a 24-hour abstinence lab session first, followed by a smoking-as-usual lab session second. All participants then received treatment.
Treatment:
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
|---|---|---|---|---|
|
Lab Session 1 (Week 1)
STARTED
|
41
|
77
|
43
|
80
|
|
Lab Session 1 (Week 1)
COMPLETED
|
41
|
77
|
43
|
76
|
|
Lab Session 1 (Week 1)
NOT COMPLETED
|
0
|
0
|
0
|
4
|
|
Lab Session 2 (Week 2)
STARTED
|
41
|
77
|
43
|
76
|
|
Lab Session 2 (Week 2)
COMPLETED
|
39
|
60
|
41
|
70
|
|
Lab Session 2 (Week 2)
NOT COMPLETED
|
2
|
17
|
2
|
6
|
|
Treatment Phase (Weeks 3-12)
STARTED
|
39
|
59
|
41
|
68
|
|
Treatment Phase (Weeks 3-12)
COMPLETED
|
38
|
48
|
37
|
63
|
|
Treatment Phase (Weeks 3-12)
NOT COMPLETED
|
1
|
11
|
4
|
5
|
Reasons for withdrawal
| Measure |
HIV+, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Participants were randomized to complete a smoking-as-usual lab session first followed by a 24-hour abstinence lab session second. All participants then received treatment.
Treatment:
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV-, Smoking Lab Session First, Abstinence Lab Session Second, Then Treatment
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Participants were randomized to complete a smoking-as-usual lab session first followed by a 24-hour abstinence lab session second. All participants then received treatment.
Treatment:
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV+, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Participants were randomized to complete a 24-hour abstinence lab session first, followed by a smoking-as-usual lab session second. All participants then received treatment.
Treatment:
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV-, Abstinence Lab Session First, Smoking-as-usual Second, Then Treatment
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Participants were randomized to complete a 24-hour abstinence lab session first, followed by a smoking-as-usual lab session second. All participants then received treatment.
Treatment:
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
|---|---|---|---|---|
|
Lab Session 1 (Week 1)
Protocol Violation
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Cognition and Smoking Relapse (HCS)
Baseline characteristics by cohort
| Measure |
HIV+
n=93 Participants
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV-
n=181 Participants
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
84 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
181 participants
n=7 Participants
|
274 participants
n=5 Participants
|
|
Cigarettes per day
|
11.6 cigarettes per day
STANDARD_DEVIATION 5.4 • n=5 Participants
|
13.3 cigarettes per day
STANDARD_DEVIATION 6.2 • n=7 Participants
|
12.7 cigarettes per day
STANDARD_DEVIATION 6.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12)Population: Numbers are different due to attrition between enrollment and lab session 1. Some cognitive data were excluded due to outliers.
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.
Outcome measures
| Measure |
HIV+ Smoking Lab Session First
n=41 Participants
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV- Smoking Lab Session First
n=77 Participants
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV+ Abstinent Lab Session First
n=43 Participants
Same as HIV+ Smoking lab session first except Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second
|
HIV- Abstinent Lab Session First
n=75 Participants
Same as HIV- Smoking lab session first except Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second
|
|---|---|---|---|---|
|
Cognitive Function
Lab session 1 (week 1)
|
0.125 z-score
Standard Deviation 0.489
|
-.093 z-score
Standard Deviation 0.441
|
-.059 z-score
Standard Deviation .452
|
-.008 z-score
Standard Deviation .553
|
|
Cognitive Function
Lab session 2 (week 2)
|
.043 z-score
Standard Deviation .498
|
-.012 z-score
Standard Deviation .441
|
-.106 z-score
Standard Deviation .488
|
.014 z-score
Standard Deviation .546
|
|
Cognitive Function
End of treatment (week 12)
|
0.149 z-score
Standard Deviation .416
|
-.082 z-score
Standard Deviation .465
|
-.091 z-score
Standard Deviation .440
|
.001 z-score
Standard Deviation .559
|
SECONDARY outcome
Timeframe: End of Treatment (week 12)Population: Only subjects who entered treatment following the two lab sessions were considered intent to treat and included in this analysis.
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.
Outcome measures
| Measure |
HIV+ Smoking Lab Session First
n=80 Participants
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV- Smoking Lab Session First
n=127 Participants
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV+ Abstinent Lab Session First
Same as HIV+ Smoking lab session first except Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second
|
HIV- Abstinent Lab Session First
Same as HIV- Smoking lab session first except Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second
|
|---|---|---|---|---|
|
7-day Point Prevalence Abstinence
|
22 Participants
|
33 Participants
|
—
|
—
|
Adverse Events
HIV+
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
HIV-
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV+
n=80 participants at risk
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV-
n=127 participants at risk
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
|---|---|---|
|
Cardiac disorders
Stroke
|
0.00%
0/80 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
0.79%
1/127 • Number of events 1 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/80 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
0.79%
1/127 • Number of events 1 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
Other adverse events
| Measure |
HIV+
n=80 participants at risk
HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
HIV-
n=127 participants at risk
HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use "the patch" in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
12.5%
10/80 • Number of events 24 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
4.7%
6/127 • Number of events 31 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
|
Skin and subcutaneous tissue disorders
Itching, burning or tingling at patch site
|
7.5%
6/80 • Number of events 12 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
5.5%
7/127 • Number of events 8 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
|
Skin and subcutaneous tissue disorders
Skin redness
|
11.2%
9/80 • Number of events 16 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
1.6%
2/127 • Number of events 3 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
|
General disorders
Sleep disturbances
|
16.2%
13/80 • Number of events 32 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
18.9%
24/127 • Number of events 48 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
|
General disorders
Vivid dreams
|
11.2%
9/80 • Number of events 13 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
10.2%
13/127 • Number of events 25 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
|
General disorders
Weakness
|
7.5%
6/80 • Number of events 7 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
6.3%
8/127 • Number of events 8 • 12 weeks: From the start of treatment through end of treatment
Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug. It was administered once treatment was initiated after both lab sessions were completed. Participants were also given an open-ended item. Groups do not distinguish by "lab session order" because the lab sessions were completed prior to the initiation of any treatment, so they are combined into HIV+ and HIV- only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place