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Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions

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ClinicalTrials.gov Identifier: NCT02432066
Recruitment Status : Not yet recruiting
First Posted : May 1, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: GTS-21 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
Estimated Study Start Date : September 29, 2018
Estimated Primary Completion Date : December 29, 2018
Estimated Study Completion Date : December 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Active Comparator: GTS-21
Participants in the GTS-21 arm will receive 150 mg/BID GTS-21 over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
Drug: GTS-21
GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.
Other Name: 3-(2,4-dimethoxybenzylidene) anabaseine (DMXB-A)

Placebo Comparator: Placebo
Participants in the Placebo arm will receive placebo compound twice daily over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
Drug: Placebo
Oral placebo pills, compounded by the UF investigational pharmacy
Other Name: Placebo Comparator




Primary Outcome Measures :
  1. Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8 [ Time Frame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 ]
    Nicotine use will be assessed using Timeline Followback procedures. Nicotine use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.

  2. Change in Carbon Monoxide (CO) from baseline at weeks 5, 8 [ Time Frame: Change in baseline at Week 5, Week 8 ]
    Expired Carbon Monoxide levels will be quantified in parts per million.

  3. Change in Urine Cotinine (COT) from baseline at weeks 5, 8 [ Time Frame: Change in baseline at Week 5, Week 8 ]
    Cotinine excreted in urine will be quantified in ng/mL


Secondary Outcome Measures :
  1. Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8 [ Time Frame: Change in baseline at Week 5, Week 8 ]
    The Beck Depression Inventory will be used to quantify depressive symptomatology. The measure is a 21-item, self-report, multiple-choice inventory, with scores ranging from 0-63.

  2. Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8 [ Time Frame: Change in baseline at Week 5, Week 8 ]
    The State Anxiety Inventory will be used to quantify anxiety symptomatology. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80.

  3. Change in State Anger (ANG-S) from baseline at weeks 5, 8 [ Time Frame: Change in baseline at Week 5, Week 8 ]
    The Spielberger State Anger Inventory will be used to assess state anger. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80.

  4. Pill Count - Week 1 [ Time Frame: Week 1 ]
    Medication compliance will be assessed with pill counts.

  5. Pill Count - Week 5 [ Time Frame: Week 5 ]
    Medication compliance will be assessed with pill counts.

  6. Pill Count - Week 8 [ Time Frame: Week 8 ]
    Medication compliance will be assessed with pill counts.

  7. Change in Minnesota Withdrawal Scale from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8 [ Time Frame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 ]
    The Minnesota Withdrawal Scale measures self-reported severity of nicotine withdrawal. The measure has 15 items, with five possible responses (0-5), thus scores on the scale range from 0 to 60.

  8. Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 1 [ Time Frame: Week 1 ]
    The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.

  9. Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 2 [ Time Frame: Week 2 ]
    The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.

  10. Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 3 [ Time Frame: Week 3 ]
    The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.

  11. Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 4 [ Time Frame: Week 4 ]
    The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.

  12. Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 5 [ Time Frame: Week 5 ]
    The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.

  13. Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 6 [ Time Frame: Week 6 ]
    The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.

  14. Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 7 [ Time Frame: Week 7 ]
    The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.

  15. Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 8 [ Time Frame: Week 8 ]
    The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.

  16. Change in Profile of Mood States 2-A from Baseline at Week 1, 2, 3, 4, 5, 6, 7, 8 [ Time Frame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 ]
    The Profile of Mood States-2 (short-form for adults) The POMS 2 is a multi-dimensional, assessment of transient moods, and states of affect. The measure includes 35 items, each rated on a 5-point scale (0-4).

  17. Rapid Visual Information Processing task (Behavior) - Baseline [ Time Frame: Baseline ]
    The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time.

  18. Rapid Visual Information Processing task - (Behavior) - Week 8 [ Time Frame: Week 8 ]
    The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time.

  19. Rapid Visual Information Processing task - (EEG) - Baseline [ Time Frame: Baseline ]
    The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.

  20. Rapid Visual Information Processing task - (EEG) - Week 8 [ Time Frame: Week 8 ]
    The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.

  21. Measurement of GTS-21 Concentration in Blood - Week 5 [ Time Frame: Week 5 ]
    Blood samples will be collected and analyzed for their concentration of GTS-21.

  22. Measurement of GTS-21 Concentration in Blood - Week 8 [ Time Frame: Week 8 ]
    Blood samples will be collected and analyzed for their concentration of GTS-21.

  23. Trail Making Test A (TMT-A) - Baseline [ Time Frame: Baseline ]
    The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.

  24. Trail Making Test A (TMT-A) - Week 5 [ Time Frame: Week 5 ]
    The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.

  25. Trail Making Test A (TMT-A) - Week 8 [ Time Frame: Week 8 ]
    The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.

  26. Trail Making Test B (TMT-B) - Baseline [ Time Frame: Baseline ]
    The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.

  27. Trail Making Test B (TMT-B) - Week 5 [ Time Frame: Week 5 ]
    The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.

  28. Trail Making Test B (TMT-B) - Week 8 [ Time Frame: Week 8 ]
    The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.

  29. N-Back Working Memory Task (Behavior) - Baseline [ Time Frame: Baseline ]
    The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include accuracy and reaction time.

  30. N-Back Working Memory Task (Behavior) - Week 8 [ Time Frame: Week 8 ]
    The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include accuracy and reaction time.

  31. N-Back Working Memory Task (EEG) - Baseline [ Time Frame: Baseline ]
    The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.

  32. N-Back Working Memory Task (EEG) - Week 8 [ Time Frame: Week 8 ]
    The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.

  33. Simple Reaction Time Test - Baseline [ Time Frame: Baseline ]
    In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.

  34. Simple Reaction Time Test - Week 5 [ Time Frame: Week 5 ]
    In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.

  35. Simple Reaction Time Test - Week 8 [ Time Frame: Week 8 ]
    In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.

  36. Little Man Test - Baseline [ Time Frame: Baseline ]
    In this computerized mental rotation test, subjects must indicate the hand in which a simulated figure holds an object. The dependent measures are accuracy and reaction time.

  37. Little Man Test - Week 8 [ Time Frame: Week 8 ]
    In this computerized mental rotation test, subjects must indicate the hand in which a simulated figure holds an object. The dependent measures are accuracy and reaction time.

  38. Visual-Perceptual Analysis Test - Baseline [ Time Frame: Baseline ]
    In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.

  39. Visual-Perceptual Analysis Test - Week 5 [ Time Frame: Week 5 ]
    In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.

  40. Visual-Perceptual Analysis Test - Week 8 [ Time Frame: Week 8 ]
    In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.

  41. Wisconsin Card Sorting Test - Baseline [ Time Frame: Baseline ]
    The Wisconsin Card Sort Test is a computerized task which requires subjects to match "cards" based on shifting matching rules which include color, shape, and number of symbols. The dependent measures for this task include accuracy and response time.

  42. Wisconsin Card Sorting Test - Week 8 [ Time Frame: Week 8 ]
    The Wisconsin Card Sort Test is a computerized task which requires subjects to match "cards" based on shifting matching rules which include color, shape, and number of symbols. The dependent measures for this task include accuracy and response time.

  43. Sternberg Short-Term Memory Test - Baseline [ Time Frame: Baseline ]
    The Sternberg Short-Term Memory Test is a computerized task in which participants are shown four digits, presented one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits, and recall the digits. The dependent variables are probe accuracy, number of correct recalls, and time to completion.

  44. Sternberg Short-Term Memory Test - Week 8 [ Time Frame: Week 8 ]
    The Sternberg Short-Term Memory Test is a computerized task in which participants are shown four digits, presented one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits, and recall the digits. The dependent variables are probe accuracy, number of correct recalls, and time to completion.

  45. Stroop Color Word Task - Baseline [ Time Frame: Baseline ]
    The Stroop Task is a measure of inhibitory control. Subjects are directed to name the colors words are printed in (i.e., "blue"), while ignoring the incongruent meaning of the words. The dependent measures include number correct and number completed.

  46. Stroop Color Word Task - Week 8 [ Time Frame: Week 8 ]
    The Stroop Task is a measure of inhibitory control. Subjects are directed to name the colors words are printed in (i.e., "blue"), while ignoring the incongruent meaning of the words. The dependent measures include number correct and number completed.

  47. Digit Symbol Substitution Task - Baseline [ Time Frame: Baseline ]
    The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.

  48. Digit Symbol Substitution Task - Week 5 [ Time Frame: Week 5 ]
    The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.

  49. Digit Symbol Substitution Task - Week 8 [ Time Frame: Week 8 ]
    The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.

  50. Metabolic Panel - Baseline [ Time Frame: Baseline ]
    Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.

  51. Metabolic Panel - Week 2 [ Time Frame: Week 2 ]
    Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.

  52. Metabolic Panel - Week 5 [ Time Frame: Week 5 ]
    Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.

  53. Metabolic Panel - Week 8 [ Time Frame: Week 8 ]
    Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.

  54. Metabolic Panel - Week 9 (Followup) [ Time Frame: Week 9 ]
    Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.

  55. Urinalysis - Baseline [ Time Frame: Baseline ]
    Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.

  56. Urinalysis - Week 2 [ Time Frame: Week 2 ]
    Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.

  57. Urinalysis - Week 5 [ Time Frame: Week 5 ]
    Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.

  58. Urinalysis - Week 8 [ Time Frame: Week 8 ]
    Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.

  59. Urinalysis - Week 9 (Followup) [ Time Frame: Week 9 ]
    Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.

  60. Electrocardiogram - Baseline [ Time Frame: Baseline ]
    Standard electrocardiographic data will be collected, including heart rate (BPM) and time between start of the Q wave and end of the T wave (QT interval).

  61. Electrocardiogram - Week 1 [ Time Frame: Week 1 ]
    Standard electrocardiographic data will be collected, including heart rate (BPM) and time between start of the Q wave and end of the T wave (QT interval).

  62. Change in Reported Drug and Alcohol Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8 [ Time Frame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 ]
    Drug and alcohol use will be assessed using Timeline Followback procedures. Drug and alcohol use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.

  63. Change in Blood Pressure from baseline at weeks 2, 5, 8, 9 [ Time Frame: Change in baseline at Week 2, Week 5, Week 8, Week 9 ]
    Systolic and Diastolic pressures will be collected.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432066


Contacts
Contact: Robert A Prather, BA 3522944942 rprather@ufl.edu
Contact: Ben Lewis, PhD 3522944920 benlewis@ufl.edu

Locations
United States, Florida
Neurocognitive Lab, University of Florida, Department of Psychiatry Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Robert A Prather, BA    352-294-4942    rprather@ufl.edu   
Contact: Ben Lewis, PhD    3522944920    benlewis@ufl.edu   
Principal Investigator: Sara J Nixon, PhD         
Sponsors and Collaborators
University of Florida
National Institutes of Health (NIH)
Investigators
Principal Investigator: Sara J Nixon, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02432066     History of Changes
Other Study ID Numbers: IRB201500393-N
Nixon2015 ( Other Identifier: Nixon )
NIH-pending ( Other Grant/Funding Number: DA038286-01A1 )
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Smoking
Smoking Cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
3-(2,4-dimethoxybenzylidene)anabaseine
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs