Nicotine AddictionPhase 2NCT01756053
Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
A Phase 2 study testing ABT-089 in people with Nicotine Addiction, run by University of Pennsylvania at 1 site in United States.
Trial summary
This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089 (an experimental medication not approved by the FDA) when administered as 40mg oral once daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive deficits, smoking withdrawal, smoking urges… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Addiction
- What is being tested?
- ABT-089
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects will be:
- Male and female smokers who are between 18 and 65 years of age and self-report smoking at least 10 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- Healthy as determined by the Study Physician, based on relevant medical history, physical examination (including vitals), and basic screening tests (CBC, CHEM7, AST/ALT).
- Smokers who wish to quit smoking in the next 2-6 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior. Using a scale from 0 to 100 (100, being extremely interested), subjects must rate their interest in quitting smoking within the next 6 months greater than 50.
- Able to communicate fluently in English (speaking, writing, and reading).
- Plan to live in the area for the next 2 months.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
Who cannot join
- Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:
- Smoking behavior.
- Current enrollment or firm plans to quit smoking and/or enroll in a smoking cessation program within the next 2 months.
- Current and/or anticipated use of any nicotine substitutes and/or smoking cessation treatments/medications within the next 2 months.
- Provide a Carbon Monoxide (CO) reading less than 11 parts per million (ppm) at Intake.
- Provide a CO reading of 10 ppm or greater at either Testing Visit (Days 6 and 37). If the CO reading is greater than or equal to 10 ppm, but there is a 50% reduction from the CO reading collected at the Baseline/Period 1 Medication Pick-Up Visit, this will be sufficient and the subject may continue as scheduled.
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- Self-report smoking during the mandatory abstinence period at either Testing Visit (Days 6 and 37).
- Regular use of chewing tobacco or snus.
- Alcohol/Drugs.
- History of substance abuse in the past 6 months and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants). Subjects reporting a history of substance abuse must be in remission at least 6 months or greater.
- Current alcohol consumption that exceeds 25 standard drinks/week.
- Provide a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at Intake, Baseline/Period 1 Medication Pick-Up, or Testing Visits (Days 6 and 37).
- A positive urine drug screen for cocaine, PCP, amphetamines, methamphetamines, tricyclic antidepressants, opiates, methadone, benzodiazepines, and/or barbiturates at Intake, Baseline/Period 1 Medication Pick-Up, Period 2 Medication Pick-Up, and Observation Visits on Days 10 and 41.
- Medical.
- Women who are pregnant, planning a pregnancy, and/or breast feeding. All female subjects will undergo a urine pregnancy test at Intake, after which only females determined to be of childbearing potential will complete a urine pregnancy test at Baseline/Period 1 Medication Pick-Up, Period 2 Medication Pick-Up, and Observation Visits on Days 10 and 41. By signing the combined consent and HIPAA form, women of childbearing potential agree to use an approved method of contraception during the study.
- Men who do not agree to use an approved method of contraception during the study. Men who are sexually active must be surgically sterile (vasectomy) or using a barrier method (condom) of birth control for the duration of the study. By signing the combined consent and HIPAA form, men agree to use an approved method of contraception.
- Current treatment of cancer or diagnosed with cancer (except basal cell carcinoma) in the past 6 months.
- Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing neurocognitive task performance.
- Color blindness.
- History of brain injury.
- History of epilepsy or a seizure disorder.
- Low or borderline intellectual functioning - determined by receiving a score of less than 90 on the Shipley Institute of Living Scale (SILS, administered at Intake), which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated IQ Test.
- Serious or unstable disease within the past 6 months (i.e., heart disease, liver/kidney failure).
- Recent history (last 6 months) of abnormal heart rhythms, tachycardia, and/or cardiovascular disease (stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case-by-case basis by the Study Physician.
- Clinically significant abnormalities determined by physical examination and collection of vital signs at Intake. Abnormalities will be assessed by the Study Physician and eligibility will be determined on a case-by-case basis.
- Uncontrolled hypertension (Systolic Blood Pressure [SBP] greater than or equal to 160 mmHg and/or Diastolic Blood Pressure [DBP] greater than or equal to 100 mmHg).
- Heart rate/pulse greater than or equal to 110 beats per minute (bpm).
- Clinically significant abnormalities in clinical chemistry (CBC, CHEM7, and AST/ALT). Results greater than 20% outside of normal range will be evaluated for clinical significance by the Study Physician and eligibility will be determined on a case-by-case basis.
- Inability to provide an assessable blood sample for basic screening tests (CBC, CHEM7, and AST/ALT) at Intake.
- Psychiatric.
- As determined by self-report, the Mini International Neuropsychiatric Interview (MINI), and/or Columbia-Suicide Severity Rating Scale (C-SSRS):
- Any suicide risk score on the MINI.
- Current (past month) suicidal ideation or lifetime suicidal behavior on the C-SSRS.
- Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
- Current diagnosis of major depression and/or recurrent major depression. Persons with a history of a single episode of major depression, in remission for 6 months or longer, are eligible provided they are not excluded based on medications (see Medication Exclusion Criteria).
- Current or past hypomanic/manic episode.
- History or current diagnosis of posttraumatic stress disorder (PTSD).
- Prior or current diagnosis of attention deficit hyperactivity disorder (ADHD).
- Medication.
- Current use or recent discontinuation (within the last 14 days at the time of Intake) of:
- Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix).
- Anti-anxiety or panic disorder medications.
- Anti-psychotic medications.
- Medications used to treat depression (e.g., Wellbutrin, MAOIs, SSRIS, tricyclic antidepressants).
- Prescription stimulants (e.g., Provigil, Ritalin, Adderall).
- Systemic corticosteroids.
- Current use of:
- Nicotine replacement therapy (NRT).
- Daily use of:
- Opiate-containing medications for chronic pain.
- Inhaled corticosteroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Feasibility Study of the Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089 (an experimental medication not approved by the FDA) when administered as 40mg oral once daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit attempt (~4 days). The key cognitive domains include: working memory, sustained attention, and response inhibition.
Read the detailed description
This is a single-site, phase IIa, double-blind, within-subject, cross-over, human laboratory study. Subjects will be healthy, treatment-seeking female and male adult smokers, ages 18 to 65 years old. Subjects deemed eligible for participation after an Intake Visit (~Day -7) will complete baseline assessments and receive period 1 medication (ABT-089 or placebo) at the Baseline Visit (Day 0). Subjects will take 40mg of ABT-089 or placebo, based on random assignment, every day for two identical 10-day study treatment periods.
Subjects will begin period 1 study medication on Day 1. On Days 3 and 5, subjects will complete in-clinic medication run-up and monitoring assessments. On Day 5, subjects will begin a ~24-hour period of mandatory abstinence from smoking. Day 6 is conducted in two parts. Part 1 will consist of confirmation of smoking abstinence, testing for abstinence-induced cognitive deficits and the collection of subjective assessments. Part 2 will begin with a programmed smoking lapse, after which the subjective rewarding value of the programmed lapse cigarette will be assessed. Before leaving the clinic on Day 6, subjects will receive brief cessation counseling and be instructed to try to remain abstinent from 10pm that evening until after the final Observation Visit on Day 10.
During the ~4-day monitored abstinence/observation phase, subjects will complete in-clinic observation visits (subjective assessments, medication adherence, etc.) on Days 7, 8, and 10.
After a ~3-week medication washout period and Period 2 Medication Pick-up Visit on ~Day 31, subjects will begin study medication (either ABT-089 or placebo; but will always be the opposite of the assigned study medication in period 1) and participate in period 2 of the study following the same procedures as period 1.
- Conditions
- Nicotine Addiction
- Being tested
- ABT-089, Placebo
- Keywords
- Smoking, Tobacco
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-089Drug
Also called Pozanicline
Selective neuronal nicotinic receptor agonist.
PlaceboDrug
Matched placebo capsules supplied by study drug supplier.
| Study group | Role | What they receive |
|---|---|---|
| ABT-089 | Active comparator | During both 10-day study medication periods (Days 1-10 \& Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order.
Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during the 10-day medication period. During study medication period 2, these subjects will take four capsules of the matched placebo capsules. Receives: Drug: ABT-089 |
| Placebo | Placebo comparator | These are matched placebo capsules manufactured by the study drug supplier.
During both 10-day study medication periods (Days 1-10 \& Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order.
Those randomized to matched placebo during study medication period 1 will take four capsules daily during the 10-day medication period. During study medication period 2, these subjects will take four 10mg capsules (40mg daily) of the active ABT-089 capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.
To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.
Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).
All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.
NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Measured: Baseline (Day 0) and Test Day (Days 6 & 37)
Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.
To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.
Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).
All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.
NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Measured: Baseline (Day 0) and Test Day (Days 6 & 37)
Secondary outcomes (6)
Effects of ABT-089 on Mood
PANAS: The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, was used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. Scores for the 10 items on each subscale were summed to create summary scores (range: 10-50); higher scores indicate greater intensity of mood (i.e., more positive or more negative affect). Higher ratings of positive affect and lower ratings of negative affect are considered better outcomes.
Measured: Days 6 and 37
Effects of ABT-089 on Withdrawal Symptoms
MNWS: The Minnesota Nicotine Withdrawal Scale - Revised version captures the current state of nicotine withdrawal. The scale assesses 15 items of nicotine withdrawal (including 7 DSM-IV items) such as: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, difficulty concentrating, restlessness, and increased appetite/weight gain. Subjects will rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe. A "withdrawal discomfort score" was calculated as the sum of the first 9 items (possible range: 0-36) and is a well-validated measure of nicotine withdrawal; a higher score indicates more severe withdrawal.
Measured: Days 6 and 37
Effects of ABT-089 on Smoking Urges/Craving
QSU-B: The 10-item brief QSU (QSU-B) questionnaire was used to assess smoking urges. Each item is rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree). A total score is calculated as the sum of the individual items (range: 10-70). Higher scores indicate more severe urges to smoke.
Measured: Days 6 and 37
Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms
ADHD symptoms: The 27-item BAARS-IV scale was used to assess current attention-deficit and hyperactive symptoms. Participant rated the intensity of their symptoms using the following scale: 1= never or rarely, 2 = sometimes, 3 = often, or 4 = very often. A total score was calculated as the sum of the individual items (range: 27-108). Higher scores indicate more frequent ADHD symptoms.
Measured: Days 6 and 37
Effects of ABT-089 on Cigarette Ratings
Cigarette evaluation scale: The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations. Items are rated on a scale from 1 ("Not at all") to 7 ("Extremely); a summary score is calculated as the mean of all responses (range: 1-7). Higher scores indicate stronger subjective effects of smoking.
Measured: Days 6 and 37
Effects of ABT-089 on Days of Biochemically-confirmed Abstinence
Daily smoking rate will be assessed at each in-person visit using the Timeline Follow-Back assessment. Abstinence will be confirmed by exhaled carbon monoxide levels during a ~4-day monitored abstinence phase within each period.
Measured: Days 7, 8, 9, 10, 38, 39, 40, & 41
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Trial discontinued based on the results of an interim futility analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caryn Lerman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756053
- Sponsor's protocol ID
- 815238
- Status last verified
- Feb 2014
- First submitted
- 19 Dec 2012
- Last updated
- 29 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of the Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
- ClinicalTrials.gov ID
- NCT01756053
- Acronym / sponsor ID
- 815238
- Conditions
- Nicotine Addiction
- Keywords
- Smoking, Tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial discontinued based on the results of an interim futility analysis.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Posted 29 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089 (an experimental medication not approved by the FDA) when administered as 40mg oral once daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit attempt (~4 days). The key cognitive domains include: working memory, sustained attention, and response inhibition.
Detailed description
This is a single-site, phase IIa, double-blind, within-subject, cross-over, human laboratory study. Subjects will be healthy, treatment-seeking female and male adult smokers, ages 18 to 65 years old. Subjects deemed eligible for participation after an Intake Visit (~Day -7) will complete baseline assessments and receive period 1 medication (ABT-089 or placebo) at the Baseline Visit (Day 0). Subjects will take 40mg of ABT-089 or placebo, based on random assignment, every day for two identical 10-day study treatment periods.
Subjects will begin period 1 study medication on Day 1. On Days 3 and 5, subjects will complete in-clinic medication run-up and monitoring assessments. On Day 5, subjects will begin a ~24-hour period of mandatory abstinence from smoking. Day 6 is conducted in two parts. Part 1 will consist of confirmation of smoking abstinence, testing for abstinence-induced cognitive deficits and the collection of subjective assessments. Part 2 will begin with a programmed smoking lapse, after which the subjective rewarding value of the programmed lapse cigarette will be assessed. Before leaving the clinic on Day 6, subjects will receive brief cessation counseling and be instructed to try to remain abstinent from 10pm that evening until after the final Observation Visit on Day 10.
During the ~4-day monitored abstinence/observation phase, subjects will complete in-clinic observation visits (subjective assessments, medication adherence, etc.) on Days 7, 8, and 10.
After a ~3-week medication washout period and Period 2 Medication Pick-up Visit on ~Day 31, subjects will begin study medication (either ABT-089 or placebo; but will always be the opposite of the assigned study medication in period 1) and participate in period 2 of the study following the same procedures as period 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT-089 | Active comparator | Drug: ABT-089During both 10-day study medication periods (Days 1-10 \& Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order. Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during the 10-day medication period. During study medication period 2, these subjects will take four capsules of the matched placebo capsules. |
| Placebo | Placebo comparator | Drug: PlaceboThese are matched placebo capsules manufactured by the study drug supplier. During both 10-day study medication periods (Days 1-10 \& Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order. Those randomized to matched placebo during study medication period 1 will take four capsules daily during the 10-day medication period. During study medication period 2, these subjects will take four 10mg capsules (40mg daily) of the active ABT-089 capsules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female smokers who are between 18 and 65 years of age and self-report smoking at least 10 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- Healthy as determined by the Study Physician, based on relevant medical history, physical examination (including vitals), and basic screening tests (CBC, CHEM7, AST/ALT).
- Smokers who wish to quit smoking in the next 2-6 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior. Using a scale from 0 to 100 (100, being extremely interested), subjects must rate their interest in quitting smoking within the next 6 months greater than 50.
- Able to communicate fluently in English (speaking, writing, and reading).
- Plan to live in the area for the next 2 months.
Key exclusion criteria (51 listed)
- Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:
- Smoking behavior.
- Alcohol/Drugs.
- Medical.
- Psychiatric.
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 |
|---|---|---|
| ABT-089Also: PozaniclineSelective neuronal nicotinic receptor agonist. | Drug | ABT-089 |
| PlaceboMatched placebo capsules supplied by study drug supplier. | Drug | Placebo |
Primary outcome
Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
Time frame: Baseline (Day 0) and Test Day (Days 6 & 37)
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)
Time frame: Baseline (Day 0) and Test Day (Days 6 & 37)
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
6 secondary outcomes
Effects of ABT-089 on Mood
Time frame: Days 6 and 37
Effects of ABT-089 on Withdrawal Symptoms
Time frame: Days 6 and 37
Effects of ABT-089 on Smoking Urges/Craving
Time frame: Days 6 and 37
Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms
Time frame: Days 6 and 37
Effects of ABT-089 on Cigarette Ratings
Time frame: Days 6 and 37
Effects of ABT-089 on Days of Biochemically-confirmed Abstinence
Time frame: Days 7, 8, 9, 10, 38, 39, 40, & 41
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CIRNA Center homepageLink provided by the sponsor.
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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.
Caryn Lerman, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-089 in people with Nicotine Addiction, run by University of Pennsylvania at 1 site in United States.
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 7 inclusion and 51 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: stopped early, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 29 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Abstinence-induced Cognitive Deficits (N-Back Accuracy) (time frame: Baseline (Day 0) and Test Day (Days 6 & 37)). The study lists 2 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 29 Oct 2014.