Trial Outcomes & Findings for TMS for Smoking Cessation in PLWHA Cessation in People Living With HIV/AIDS (PLWHA) (NCT NCT04936594)

NCT ID: NCT04936594

Last Updated: 2023-07-13

Results Overview

Cues Encompassing People Smoking Cigarettes. Measured after iTBS using visual probe task administered (adapted for smoking images) on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

baseline and immediately after intervention, approximately 4 hours

Results posted on

2023-07-13

Participant Flow

A total of 9 participants were enrolled; however, 1 participant dropped out before the experimental sessions began.

Participant milestones

Participant milestones
Measure	People Living With HIV/AIDS Who Smoke Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS (Intermittent Theta Burst Stimulation) and a sham comparator (TMS).
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TMS for Smoking Cessation in PLWHA Cessation in People Living With HIV/AIDS (PLWHA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	People Living With HIV/AIDS Who Smoke n=8 Participants Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS).
Age, Continuous	42.88 years STANDARD_DEVIATION 3.45 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and immediately after intervention, approximately 4 hours

Cues Encompassing People Smoking Cigarettes. Measured after iTBS using visual probe task administered (adapted for smoking images) on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

Outcome measures

Outcome measures
Measure	People Living With HIV/AIDS (PLWHA) Who Smoke n=8 Participants Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS).
Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking Baseline	1007.05 milliseconds Standard Error 148.70
Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking After Intervention	566.89 milliseconds Standard Error 121.70

PRIMARY outcome

Timeframe: baseline and immediately after intervention, approximately 4 hours

Population: 3 participants who got itbs did not show up for the sham visit

Cues Encompassing People Smoking Cigarettes. Measured after sham using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

Outcome measures

Outcome measures
Measure	People Living With HIV/AIDS (PLWHA) Who Smoke n=5 Participants Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS).
Change in Attentional Bias Sham Smoking Baseline	884.60 milliseconds Standard Error 112.77
Change in Attentional Bias Sham Smoking After Intervention	658.67 milliseconds Standard Error 148.63

PRIMARY outcome

Timeframe: baseline and immediately after intervention, approximately 4 hours

Cues Encompassing Cigarette Paraphernalia. Measured after iTBS using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of cigarette paraphernalia and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

Outcome measures

Outcome measures
Measure	People Living With HIV/AIDS (PLWHA) Who Smoke n=8 Participants Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS).
Change in Attentional Bias iTBS Paraphernalia Baseline	670.43 milliseconds Standard Error 139.26
Change in Attentional Bias iTBS Paraphernalia After Intervention	443.10 milliseconds Standard Error 136.37

PRIMARY outcome

Timeframe: baseline and immediately after intervention, approximately 4 hours

Population: 3 participants who got itbs did not show up for the sham visit

Cues Encompassing Cigarette Paraphernalia. Measured after sham using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of cigarette paraphernalia and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

Outcome measures

Outcome measures
Measure	People Living With HIV/AIDS (PLWHA) Who Smoke n=5 Participants Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS).
Change in Attentional Bias Sham Paraphernalia Baseline	528.38 milliseconds Standard Error 139.39
Change in Attentional Bias Sham Paraphernalia After Intervention	307.56 milliseconds Standard Error 135.26

SECONDARY outcome

Timeframe: baseline and immediately after intervention, approximately 4 hours

Craving measured using TCQ-SF. The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving.

Outcome measures

Outcome measures
Measure	People Living With HIV/AIDS (PLWHA) Who Smoke n=8 Participants Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS).
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS Baseline	55.88 score on a scale Standard Error 3.95
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS After Intervention	43.13 score on a scale Standard Error 4.68

SECONDARY outcome

Timeframe: baseline and immediately after intervention, approximately 4 hours

Population: All participants completed the iTBS session but 3 participants did not show up for the sham visit

Craving measured using TCQ-SF. The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving.

Outcome measures

Outcome measures
Measure	People Living With HIV/AIDS (PLWHA) Who Smoke n=5 Participants Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS).
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham Baseline	53.2 score on a scale Standard Error 4.77
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham After Intervention	48.40 score on a scale Standard Error 6.84

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Measured in MRI scanner

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Four hours from baseline

Measured in MRI scanner

Outcome measures

Outcome data not reported

Adverse Events

People Living With HIV/AIDS (PLWHA) Who Smoke

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gopalkumar Rakesh

University of Kentucky

Phone: 859-562-2348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place