Clinical trial NCT02432066: Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
Official title: Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: Smoking
Smoking Cessation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. These effects, in turn, may contribute to smoking relapse. This exploratory/developmental project examines the effects of a novel medication, GTS-21, on individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.

Detailed description: The project is a clinical trial assessing the effects of GTS-21 (an α7 nicotinic receptor partial agonist) on smoking, mood, neurocognition, and neurophysiology, in a small sample of chronic smokers who are currently healthy and interested in smoking cessation. Using a double-blind, placebo controlled, parallel group design, 54 (27 women) community smokers who have demonstrated a readiness to quit will participate over a 7 week active trial. Subjects will be randomly assigned to active drug or placebo groups. Across the study period, participants will undergo repeated neurobehavioral testing, laboratory assessments of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood state and side-effects.

Eligibility criteria: Inclusion Criteria:

* Minimum of 12 years of education
* Must report typical daily smoking of \> 10 cigarettes/day over the previous year
* Must report a history of at least 3 years of regular smoking
* Must provide carbon monoxide measures of at least 6.5 ppm
* Must report a willingness to quit smoking

Exclusion Criteria:

* Participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months.
* Must not meet criteria for other substance dependence or major psychiatric disorders.
* Must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nAChR sites. This list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled Type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates).
* Must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes
* Must not report current use of nicotine replacement therapies (i.e., occasions of \> 4 h/week during a typical week, even if not used as a cessation aid)
* Must not have used bupropion within the previous year
* Must not report any past use (regardless of year) of varenicline
* Women may not be breastfeeding, pregnant or intending to become pregnant during the study period

Primary outcomes:
measure: Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
timeFrame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
measure: Change in Carbon Monoxide (CO) from baseline at weeks 5, 8
timeFrame: Change in baseline at Week 5, Week 8
measure: Change in Urine Cotinine (COT) from baseline at weeks 5, 8
timeFrame: Change in baseline at Week 5, Week 8
Secondary outcomes:
measure: Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8
timeFrame: Change in baseline at Week 5, Week 8
measure: Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8
timeFrame: Change in baseline at Week 5, Week 8
measure: Change in State Anger (ANG-S) from baseline at weeks 5, 8
timeFrame: Change in baseline at Week 5, Week 8
measure: Pill Count - Week 1
timeFrame: Week 1
measure: Pill Count - Week 5
timeFrame: Week 5
measure: Pill Count - Week 8
timeFrame: Week 8
measure: Change in Minnesota Withdrawal Scale from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
timeFrame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 1
timeFrame: Week 1
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 2
timeFrame: Week 2
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 3
timeFrame: Week 3
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 4
timeFrame: Week 4
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 5
timeFrame: Week 5
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 6
timeFrame: Week 6
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 7
timeFrame: Week 7
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 8
timeFrame: Week 8
measure: Change in Profile of Mood States 2-A from Baseline at Week 1, 2, 3, 4, 5, 6, 7, 8
timeFrame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
measure: Rapid Visual Information Processing task (Behavior) - Baseline
timeFrame: Baseline
measure: Rapid Visual Information Processing task - (Behavior) - Week 8
timeFrame: Week 8
measure: Rapid Visual Information Processing task - (EEG) - Baseline
timeFrame: Baseline
measure: Rapid Visual Information Processing task - (EEG) - Week 8
timeFrame: Week 8
measure: Measurement of GTS-21 Concentration in Blood - Week 5
timeFrame: Week 5
measure: Measurement of GTS-21 Concentration in Blood - Week 8
timeFrame: Week 8
measure: Trail Making Test A (TMT-A) - Baseline
timeFrame: Baseline
measure: Trail Making Test A (TMT-A) - Week 5
timeFrame: Week 5
measure: Trail Making Test A (TMT-A) - Week 8
timeFrame: Week 8
measure: Trail Making Test B (TMT-B) - Baseline
timeFrame: Baseline
measure: Trail Making Test B (TMT-B) - Week 5
timeFrame: Week 5
measure: Trail Making Test B (TMT-B) - Week 8
timeFrame: Week 8
measure: N-Back Working Memory Task (Behavior) - Baseline
timeFrame: Baseline
measure: N-Back Working Memory Task (Behavior) - Week 8
timeFrame: Week 8
measure: N-Back Working Memory Task (EEG) - Baseline
timeFrame: Baseline
measure: N-Back Working Memory Task (EEG) - Week 8
timeFrame: Week 8
measure: Simple Reaction Time Test - Baseline
timeFrame: Baseline
measure: Simple Reaction Time Test - Week 5
timeFrame: Week 5
measure: Simple Reaction Time Test - Week 8
timeFrame: Week 8
measure: Little Man Test - Baseline
timeFrame: Baseline
measure: Little Man Test - Week 8
timeFrame: Week 8
measure: Visual-Perceptual Analysis Test - Baseline
timeFrame: Baseline
measure: Visual-Perceptual Analysis Test - Week 5
timeFrame: Week 5
measure: Visual-Perceptual Analysis Test - Week 8
timeFrame: Week 8
measure: Wisconsin Card Sorting Test - Baseline
timeFrame: Baseline
measure: Wisconsin Card Sorting Test - Week 8
timeFrame: Week 8
measure: Sternberg Short-Term Memory Test - Baseline
timeFrame: Baseline
measure: Sternberg Short-Term Memory Test - Week 8
timeFrame: Week 8
measure: Stroop Color Word Task - Baseline
timeFrame: Baseline
measure: Stroop Color Word Task - Week 8
timeFrame: Week 8
measure: Digit Symbol Substitution Task - Baseline
timeFrame: Baseline
measure: Digit Symbol Substitution Task - Week 5
timeFrame: Week 5
measure: Digit Symbol Substitution Task - Week 8
timeFrame: Week 8
measure: Metabolic Panel - Baseline
timeFrame: Baseline
measure: Metabolic Panel - Week 2
timeFrame: Week 2
measure: Metabolic Panel - Week 5
timeFrame: Week 5
measure: Metabolic Panel - Week 8
timeFrame: Week 8
measure: Metabolic Panel - Week 9 (Followup)
timeFrame: Week 9
measure: Urinalysis - Baseline
timeFrame: Baseline
measure: Urinalysis - Week 2
timeFrame: Week 2
measure: Urinalysis - Week 5
timeFrame: Week 5
measure: Urinalysis - Week 8
timeFrame: Week 8
measure: Urinalysis - Week 9 (Followup)
timeFrame: Week 9
measure: Electrocardiogram - Baseline
timeFrame: Baseline
measure: Electrocardiogram - Week 1
timeFrame: Week 1
measure: Change in Reported Drug and Alcohol Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
timeFrame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
measure: Change in Blood Pressure from baseline at weeks 2, 5, 8, 9
timeFrame: Change in baseline at Week 2, Week 5, Week 8, Week 9
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Sara J Nixon, PhD
role: PRINCIPAL_INVESTIGATOR
References: