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Tobacco Use DisorderPhase 2GAL-KNCT01669538

Effect of Galantamine on Short-term Abstinence

A Phase 2 study testing Galantamine in people with Tobacco Use Disorder, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled study to test whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Tobacco Use Disorder
What is being tested?
Galantamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
1 siteUnited States
Study dates
Aug 2012to Nov 2017
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Smokers who are between 18 and 60 years of age who self-report smoking at least 10 cigarettes (menthol and non-menthol) per day for at least the last 6 months.
  • Interest in quitting smoking in the next 2 to 6 months.
  • Healthy as determined by the Study Physician, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
  • Women of childbearing potential must consent to use a medically accepted method of birth control while participating in the study (e.g., condoms and spermicide, oral contraceptive, Depo-provera injection, contraceptive patch, tubal ligation).

Who cannot join

  • Smoking behavior
  • Use of chewing tobacco, snuff, and/or snus.
  • Current enrollment in a smoking cessation program, or use of other smoking cessation medications in the last month or plans to do either in the next 2 months.
  • Provide a carbon monoxide (CO) breath sample reading less than 10 parts per million (ppm) at either the Intake or Baseline visits.
  • Alcohol/Drugs
  • Lifetime history of substance abuse (other than nicotine) and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, stimulants, PCP, benzodiazepines, or study-prohibited medications/recreational drugs) as determined by self-report during the phone screen and/or through the MINI during the Intake visit.
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  • Current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months.
  • Providing a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at the Intake, Baseline, or Testing Days.
  • A positive urine drug screen for cocaine, amphetamines, methamphetamines, benzodiazepines, PCP, methadone, barbiturates, and opiates at the Intake visit, Baseline visit, or the Testing days.
  • Medical
  • Women who are pregnant, planning a pregnancy in the next 3 months, or lactating; all female subjects shall undergo a urine pregnancy test at the Intake visit and must agree in writing to use an approved method of contraception. Following enrollment, pregnancy tests will be conducted at the Baseline visit and Testing days for all female subjects of child-bearing potential.
  • Diagnosis of Alzheimer's Disease or dementia.
  • Current treatment of cancer or diagnosed with cancer (except basal cell carcinoma) in the past 6 months.
  • Liver/kidney failure, peptic ulcer disease, benign prostate hypertrophy.
  • Asthma or chronic obstructive pulmonary disease (COPD).
  • History (last 6 months) of abnormal heart rhythms, tachycardia and/or cardiovascular disease (stroke, angina, heart attack). These conditions will be evaluated on a case by case basis by the Study Physician/Health Care Provider.
  • Serious or unstable disease within the past 6 months, as determined by the Study Physician/Health Care Provider.
  • Clinically significant abnormalities within physical examination and vital signs at Medical Screen. Abnormalities will be assessed by the Study Physician/Health Care Provider and eligibility will be determined on a case-by-case basis.
  • Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.
  • Uncontrolled high blood pressure (Systolic BP greater than 160 and/or Diastolic BP greater than 100).
  • Hearing impairment, significant hearing loss (more than 20% in either ear), cochlear implants, or bi-lateral hearing aids.
  • History of brain injury.
  • History of epilepsy or a seizure disorder.
  • Color Blindness.
  • Low or borderline intellectual functioning - determined by receiving a score of less than 90 on the Shipley Institute of Living Scale (SILS) which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated IQ Test (administered at the Intake visit).
  • Psychiatric Exclusions (determined by self-report on phone screen and/or through the MINI during the Intake visit)
  • Current diagnosis of major depression. Persons with a history of major depression, in remission for 6 months or longer, are eligible, provided they are not excluded based on medications (below).
  • Suicide risk score on MINI greater than 0.
  • History or current diagnosis of schizophrenia, psychosis, and/or bipolar disorder.
  • Current or past hypomanic/manic episode.
  • Current or history of a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD).
  • Medication
  • Current use, recent discontinuation (within the last month) of any form of smoking cessation medications (i.e., Zyban, Wellbutrin, Wellbutrin SR, Chantix, nicotine replacement therapy).
  • Current use or recent discontinuation (within the last 60 days) of any of the following:
  • Anti-anxiety or panic disorder medications.
  • Anti-psychotic medications.
  • Mood-stabilizers (e.g., Lithium, Lamictal/lamotrigine, Neurontin/gabapentin, Topamax/topiramate, valproic acid, Tegretol/carbamazepine).
  • Anti-depressants (e.g., Wellbutrin, MAOIs, SSRIs, tricyclic antidepressants).
  • Prescription stimulants (e.g., Provigil, Ritalin, Adderall).
  • Systemic Steroids (e.g., Prednisone).
  • Alzheimer's disease medications (e.g., Acetylcholinesterase inhibitors (ACIs), Aricept/donepezil, Exelon/rivastigmine, Tacrine, or memantine).
  • Parkinson's disease medications(e.g., Cogentin/benztropine).
  • Irritable bowel syndrome medication (e.g., Dicylomine/Bentyl).
  • Heart medications (e.g., quinidine or Procardia/nifedipine).
  • Peptic ulcer disease medication (e.g, Zantac/ranitidine).
  • Muscle relaxants (e.g., Soma/carisoprodol, Anectine/succinylcholine).
  • Anti-fungal medication (e.g., Nizoral/ketoconazole).
  • Anti-seizure medications (e.g., Ativan, Banzel, Carbatrol, Dilantin, Lamictal, Gabitril, Lyrica, Neurontin, Tegretol, Topamax).
  • COPD medication (e.g., Atrovent/Ipratropium Bromide).
  • Urinary retention medications (e.g., Duvoid/bethanechol, Proscar/finasteride, Avodart/dutasteride, Dibenzyline/phenoxybenzamine, Regitine/phentolamine).
  • Eye medication (e.g., Atropine).
  • Daily use of any of the following:
  • Opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin).
  • Medication for asthma (albuterol, Serevent, Combivent, Advair, Flovent, Azmacort, Symbicort).
  • Known drug allergy to the study medication.
  • Subjects will be instructed to refrain from using any study prohibited drugs/medications (both recreational and prescription) throughout their participation in the study. After final eligibility is confirmed, subjects who report taking contraindicated medication(s) over the course of the study period may only remain eligible if the Study Physician and/or Principal Investigator determines that the contraindicated medication(s) do/did not impact the study design, data quality, and/or subject safety/welfare. Subjects are permitted to take necessary prescription medications not included within the exclusion list during the study.
  • General exclusions
  • Current, anticipated, or pending enrollment in another research program over the next 2-3 months that could potentially affect subject safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician.
  • Not planning to live in the area for the next two months.
  • Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
  • Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
  • Completion of neurocognitive assessments and/or use of study medication(s) at the CIRNA in the past 6-months that could influence performance on study tasks as determined by the Principal Investigator.
  • Not able to effectively communicate in English (reading, writing, speaking).
  • Missing 2 or more consecutive sessions, or 3 or more sessions during the medication period.
  • Missing 2 or more consecutive doses during the medication period.
  • Missing 3 or more doses throughout the medication period.

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

Other trials in United States

About this study

Official title: Repurposing Cholinesterase Inhibitors for Smoking Cessation.

This is a randomized, double-blind, placebo-controlled study to test whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt.

Read the detailed description

Galantamine, an FDA-approved treatment for Alzheimer's disease, is used to treat cognitive impairment by enhancing acetylcholine through inhibition of the enzyme, acetylcholinesterase. We propose randomized double-blind placebo-controlled study of short-term (23 days) treatment with galantamine.

Eighty chronic smokers will complete a validated procedure for screening new medications. An equal number of subjects will be assigned to one of two groups: galantamine-ER or placebo. Participants in both groups will take one capsule each day and follow the same procedures. This is not a cross-over trial.

For participants in the galantamine group, following an initial 1-week drug run-up phase (8mg daily of galantamine-ER), the medication dose will be increased to 16mg daily of galantamine-ER for the remainder of the study (up to Day 23).

On Day 15, smokers will begin a mandatory 24-hour abstinence period, which will be followed by a programmed smoking lapse on Day 16. Smokers will then be instructed to abstain for the following 7 days (observed abstinence). Following completion of the study, participants will be offered standard smoking cessation treatment.

On Days 0 (Baseline), 14, and 16, subjects will perform the following computer tasks: a working memory task (Visual/Spatial N-Back), sustained attention tasks (Penn Continuous Performance Task [PCPT-nl] and XO Reaction Time Task), a recall memory task (Word Recognition), an interference control task (Stroop test), and a response inhibition task (Stop Signal Task).

The primary outcome is to identify changes in behavioral performance and subjective symptoms following two weeks treatment of galantamine and after 24 hours of abstinence, compared to baseline.

This study will provide information about the role of the cholinergic system during brief abstinence and whether enhancing acetylcholine reduces abstinence-induced cognitive symptoms that promote smoking relapse. Information obtained in this study may further establish cognitive performance measures as endophenotypes for nicotine dependence.

Being tested
Galantamine, Placebo
Keywords
Galantamine, Nicotine Bitartrate, Nicotine Tartrate, Nicotine dependence, Tobacco Dependence
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalantamineDrug

    Also called Galantamine hydrobromide ER, Razadyne ER

  • PlaceboDrug

    Also called Sugar pill

Study groups in NCT01669538
Study groupRoleWhat they receive
GalantamineExperimentalGalantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication. Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Receives: Drug: Galantamine
PlaceboPlacebo comparatorParticipants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment. Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Smoke-free Days (Biochemically Verified) During a 7-day Quit Attempt.

    Day 17 will be the beginning of a 7-day quit attempt, during which the total number of days of abstinence will be assessed.

    Measured: Days 17-23

Secondary outcomes (3)

  1. Cognitive Performance

    Participants will complete neurocognitive tests designed to test working memory and attention. These tests are similar to computer games, in that participants will push a button in response to the pictures they see.

    Measured: Baseline (Day 0), Day 14 (day before start of 24-hour abstinence period), Day 16 (after 24-hour abstinence period ends)

  2. Subjective Symptoms

    Smoking urges [Questionnaire of Smoking Urges-Brief; QSU-B; 10-items rated on a 7-point scale (1=strongly disagree, 7=strongly agree) and summed for total score (range: 10-70). Higher scores=greater urge to smoke.] Negative mood [Negative Affect scale (10 items) from the Positive and Negative Affect Schedule; PANAS; 20-item Likert-format measure; The subscale was summed to create a summary score (range: 10-50); Lower negative affect indicates better outcomes.] Nicotine withdrawal [Minnesota Nicotine Withdrawal Scale-Revised; MNWS-R; 15 symptoms are rated on intensity with the following scale: 0=none, 1=slight, 2=mild, 3=moderate, 4=severe. The first 9 items are summed for total score (range: 0-36); higher scores=more severe withdrawal.].

    Measures assessed at the following visits: Baseline; Day 7 (monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (7-day quit attempt).

    Measured: Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23

  3. Common Side Effects of Galantamine Check List

    Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects rated the severity of 37 common side effects of galantamine on the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The average of all items was used to create a summary side effect score (range for total summary score 0-3). Higher scores indicate greater severity of side effects.

    Side effects of galantamine were assessed at the following in-person sessions: Baseline session; Day 7 (brief monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (during the 7-day quit attempt).

    Measured: Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01669538
Sponsor's protocol ID
815789
Other IDs
UPCC15912, K23DA035295
Acronym
GAL-K
Status last verified
Jan 2019
First submitted
16 Aug 2012
Last updated
15 Feb 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Galantamine in people with Tobacco Use Disorder, 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 5 inclusion and 66 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: finished, as of the sponsor's last update on 15 Feb 2019. 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 15 Feb 2019). 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?

Total Number of Smoke-free Days (Biochemically Verified) During a 7-day Quit Attempt. (time frame: Days 17-23). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01669538.

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 15 Feb 2019.

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