Study Summary
This trial will test a new treatment for smokers that includes exposure to smoking-related stimuli combined with brain stimulation in an attempt to reduce smoking and increase the intent to quit.
Eligible Conditions
- Smoking
- Smoking/Cigarette Smoking
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 6 Secondary · Reporting Duration: Baseline to approximately 6 weeks
Week 1
Age as a moderator of cue-induced craving
Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cue-induced craving.
Mean Change from baseline in 4-item Questionnaire on Smoking Urges craving score during cue reactivity to personal cues
Sex as a moderator of cue-induced craving
Week 6
Age as a moderator of of cigarettes smoked per day
Baseline measure of Fagerstrom Test of Nicotine Dependence (FTND) as moderator of cigarettes per day
Sex as a moderator of cigarettes smoked per day
Baseline to approximately 6-weeks
Mean Change from baseline in number cigarettes smoked daily
Mean Change from baseline in rating score for 5-item Intent to Quit Questionnaire
Mean Change from baseline in rating score for Confidence to Quit Questionnaire
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
AC + tDCS
1 of 4
AAT + tDCS
1 of 4
AAT + sham tDCS
1 of 4
AC + sham tDCS
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group
80 Total Participants · 4 Treatment Groups
Primary Treatment: Approach/Avoidance Task · Has Placebo Group · N/A
AAT + tDCSExperimental Group · 2 Interventions: Approach/Avoidance Task, Transcranial Direct Current Stimulation · Intervention Types: Behavioral, Device
AAT + sham tDCSShamComparator Group · 2 Interventions: Approach/Avoidance Task, Sham tDCS · Intervention Types: Behavioral, Device
AC + sham tDCSShamComparator Group · 2 Interventions: AC, Sham tDCS · Intervention Types: Behavioral, Device
AC + tDCSActiveComparator Group · 2 Interventions: AC, Transcranial Direct Current Stimulation · Intervention Types: Behavioral, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1150
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to approximately 6 weeks
Who is running the clinical trial?
Cynthia ConklinLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,250 Previous Clinical Trials
2,029,272 Total Patients Enrolled
62 Trials studying Smoking
18,905 Patients Enrolled for Smoking
Cynthia Conklin, PhDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
92 Total Patients Enrolled
Eligibility Criteria
Age 26 - 55 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You smoke more than 7 cigarettes per day.
You have the ability to attend 10 sessions over a 3-week period, and complete 2 follow-up phone assessments.
You are between the ages of 26 and 55.\n
Who else is applying?
What state do they live in?
| Michigan | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
How many prior treatments have patients received?
| 3+ | 100.0% |
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Conditions
Cancer Related
Treatments