Tobacco Use DisorderPhase 2NCT02432066
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
A Phase 2 study testing GTS-21 in people with Tobacco Use Disorder, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- GTS-21
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2018to 29 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- GTS-21, Placebo
- Keywords
- Smoking, Smoking Cessation
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTS-21Drug
Also called 3-(2,4-dimethoxybenzylidene) anabaseine (DMXB-A)
GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.
PlaceboDrug
Also called Placebo Comparator
Oral placebo pills, compounded by the UF investigational pharmacy
| Study group | Role | What they receive |
|---|---|---|
| GTS-21 | Active comparator | 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. Receives: Drug: GTS-21 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 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.
Measured: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Change in Carbon Monoxide (CO) from baseline at weeks 5, 8
Expired Carbon Monoxide levels will be quantified in parts per million.
Measured: Change in baseline at Week 5, Week 8
Change in Urine Cotinine (COT) from baseline at weeks 5, 8
Cotinine excreted in urine will be quantified in ng/mL
Measured: Change in baseline at Week 5, Week 8
Secondary outcomes (63)
Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 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.
Measured: Change in baseline at Week 5, Week 8
Change in State Anxiety Inventory (AI) from baseline at weeks 5, 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.
Measured: Change in baseline at Week 5, Week 8
Change in State Anger (ANG-S) from baseline at weeks 5, 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.
Measured: Change in baseline at Week 5, Week 8
Pill Count - Week 1
Medication compliance will be assessed with pill counts.
Measured: Week 1
Pill Count - Week 5
Medication compliance will be assessed with pill counts.
Measured: Week 5
Pill Count - Week 8
Medication compliance will be assessed with pill counts.
Measured: Week 8
Change in Minnesota Withdrawal Scale from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 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.
Measured: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Systematic Assessment for Treatment Emergent Events (SAFTEE) - 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.
Measured: Week 1
Systematic Assessment for Treatment Emergent Events (SAFTEE) - 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.
Measured: Week 2
Systematic Assessment for Treatment Emergent Events (SAFTEE) - 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.
Measured: Week 3
Systematic Assessment for Treatment Emergent Events (SAFTEE) - 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.
Measured: Week 4
Systematic Assessment for Treatment Emergent Events (SAFTEE) - 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.
Measured: Week 5
Systematic Assessment for Treatment Emergent Events (SAFTEE) - 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.
Measured: Week 6
Systematic Assessment for Treatment Emergent Events (SAFTEE) - 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.
Measured: Week 7
Systematic Assessment for Treatment Emergent Events (SAFTEE) - 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.
Measured: Week 8
Change in Profile of Mood States 2-A from Baseline at Week 1, 2, 3, 4, 5, 6, 7, 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).
Measured: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Rapid Visual Information Processing task (Behavior) - 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.
Measured: Baseline
Rapid Visual Information Processing task - (Behavior) - 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.
Measured: Week 8
Rapid Visual Information Processing task - (EEG) - 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.
Measured: Baseline
Rapid Visual Information Processing task - (EEG) - 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.
Measured: Week 8
Measurement of GTS-21 Concentration in Blood - Week 5
Blood samples will be collected and analyzed for their concentration of GTS-21.
Measured: Week 5
Measurement of GTS-21 Concentration in Blood - Week 8
Blood samples will be collected and analyzed for their concentration of GTS-21.
Measured: Week 8
Trail Making Test A (TMT-A) - 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.
Measured: Baseline
Trail Making Test A (TMT-A) - 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.
Measured: Week 5
Trail Making Test A (TMT-A) - 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.
Measured: Week 8
Trail Making Test B (TMT-B) - 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.
Measured: Baseline
Trail Making Test B (TMT-B) - 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.
Measured: Week 5
Trail Making Test B (TMT-B) - 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.
Measured: Week 8
N-Back Working Memory Task (Behavior) - 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.
Measured: Baseline
N-Back Working Memory Task (Behavior) - 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.
Measured: Week 8
N-Back Working Memory Task (EEG) - 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.
Measured: Baseline
N-Back Working Memory Task (EEG) - 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.
Measured: Week 8
Simple Reaction Time Test - 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.
Measured: Baseline
Simple Reaction Time Test - 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.
Measured: Week 5
Simple Reaction Time Test - 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.
Measured: Week 8
Little Man Test - 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.
Measured: Baseline
Little Man Test - 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.
Measured: Week 8
Visual-Perceptual Analysis Test - 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.
Measured: Baseline
Visual-Perceptual Analysis Test - 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.
Measured: Week 5
Visual-Perceptual Analysis Test - 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.
Measured: Week 8
Wisconsin Card Sorting Test - 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.
Measured: Baseline
Wisconsin Card Sorting Test - 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.
Measured: Week 8
Sternberg Short-Term Memory Test - 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.
Measured: Baseline
Sternberg Short-Term Memory Test - 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.
Measured: Week 8
Stroop Color Word Task - 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.
Measured: Baseline
Stroop Color Word Task - 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.
Measured: Week 8
Digit Symbol Substitution Task - 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.
Measured: Baseline
Digit Symbol Substitution Task - 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.
Measured: Week 5
Digit Symbol Substitution Task - 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.
Measured: Week 8
Metabolic Panel - 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.
Measured: Baseline
Metabolic Panel - 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.
Measured: Week 2
Metabolic Panel - 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.
Measured: Week 5
Metabolic Panel - 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.
Measured: Week 8
Metabolic Panel - Week 9 (Followup)
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.
Measured: Week 9
Urinalysis - Baseline
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Measured: Baseline
Urinalysis - Week 2
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Measured: Week 2
Urinalysis - Week 5
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Measured: Week 5
Urinalysis - Week 8
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Measured: Week 8
Urinalysis - Week 9 (Followup)
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Measured: Week 9
Electrocardiogram - 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).
Measured: Baseline
Electrocardiogram - 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).
Measured: Week 1
Change in Reported Drug and Alcohol Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 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.
Measured: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Change in Blood Pressure from baseline at weeks 2, 5, 8, 9
Systolic and Diastolic pressures will be collected.
Measured: Change in baseline at Week 2, Week 5, Week 8, Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study start29 Sep 2018 (estimated)
- Primary completion29 Dec 2018 (estimated)
- Study completion29 Dec 2020 (estimated)
Why it stopped: Study was not started and participants were not enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sara J Nixon, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432066
- Sponsor's protocol ID
- IRB201500393
- Other IDs
- Nixon2015, R21DA038286
- Status last verified
- Mar 2019
- First submitted
- 28 Apr 2015
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
- ClinicalTrials.gov ID
- NCT02432066
- Acronym / sponsor ID
- IRB201500393
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking, Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not started and participants were not enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Sep 2018 (estimated)
- Primary completion
- 29 Dec 2018 (estimated)
- Study completion
- 29 Dec 2020 (estimated)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GTS-21 | Active comparator | Drug: GTS-21Participants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTS-21Also: 3-(2,4-dimethoxybenzylidene) anabaseine (DMXB-A)GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally. | Drug | GTS-21 |
| PlaceboAlso: Placebo ComparatorOral placebo pills, compounded by the UF investigational pharmacy | Drug | Placebo |
Primary outcome
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.
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.
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
63 secondary outcomes
Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8
Time frame: Change in baseline at Week 5, Week 8
Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8
Time frame: Change in baseline at Week 5, Week 8
Change in State Anger (ANG-S) from baseline at weeks 5, 8
Time frame: Change in baseline at Week 5, Week 8
Pill Count - Week 1
Time frame: Week 1
Pill Count - Week 5
Time frame: Week 5
Pill Count - Week 8
Time frame: Week 8
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
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 1
Time frame: Week 1
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 2
Time frame: Week 2
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 3
Time frame: Week 3
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 4
Time frame: Week 4
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 5
Time frame: Week 5
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 6
Time frame: Week 6
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 7
Time frame: Week 7
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 8
Time frame: Week 8
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
Rapid Visual Information Processing task (Behavior) - Baseline
Time frame: Baseline
Rapid Visual Information Processing task - (Behavior) - Week 8
Time frame: Week 8
Rapid Visual Information Processing task - (EEG) - Baseline
Time frame: Baseline
Rapid Visual Information Processing task - (EEG) - Week 8
Time frame: Week 8
Measurement of GTS-21 Concentration in Blood - Week 5
Time frame: Week 5
Measurement of GTS-21 Concentration in Blood - Week 8
Time frame: Week 8
Trail Making Test A (TMT-A) - Baseline
Time frame: Baseline
Trail Making Test A (TMT-A) - Week 5
Time frame: Week 5
Trail Making Test A (TMT-A) - Week 8
Time frame: Week 8
Trail Making Test B (TMT-B) - Baseline
Time frame: Baseline
Trail Making Test B (TMT-B) - Week 5
Time frame: Week 5
Trail Making Test B (TMT-B) - Week 8
Time frame: Week 8
N-Back Working Memory Task (Behavior) - Baseline
Time frame: Baseline
N-Back Working Memory Task (Behavior) - Week 8
Time frame: Week 8
N-Back Working Memory Task (EEG) - Baseline
Time frame: Baseline
N-Back Working Memory Task (EEG) - Week 8
Time frame: Week 8
Simple Reaction Time Test - Baseline
Time frame: Baseline
Simple Reaction Time Test - Week 5
Time frame: Week 5
Simple Reaction Time Test - Week 8
Time frame: Week 8
Little Man Test - Baseline
Time frame: Baseline
Little Man Test - Week 8
Time frame: Week 8
Visual-Perceptual Analysis Test - Baseline
Time frame: Baseline
Visual-Perceptual Analysis Test - Week 5
Time frame: Week 5
Visual-Perceptual Analysis Test - Week 8
Time frame: Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara J Nixon, PhD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GTS-21 in people with Tobacco Use Disorder, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.