Effect of Galantamine on Short-term Abstinence

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01845961
First received: May 1, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

The objective of this proof-of-concept pilot study to evaluate galantaminehydrobromide extended-release (ER) as a potential smoking cessation aid in treatment-seeking smokers.


Condition Intervention Phase
Treatment-seeking Smokers, Reporting Consumption of at Least 10 Cigarettes
Per Day for at Least the Past 6 Months
Drug: Galantamine Hydrobromide-ER
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Repurposing Cholinesterase Inhibitors for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 107
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Galantamine Hydrobromide-ER
    8mg and 16 mg
Detailed Description:

Nicotine dependence is a major public health problem and currently available treatments are ineffective for the majority of smokers. Thus, there is an urgent need to develop and test new medications to aid in smoking cessation. Recent evidence from a genetic study of prospective smoking cessation conducted at the CIRNA suggested smoking cessation may be influenced by variationin acetylcholine levels. The proposed proof-of-concept study is a randomized, double-blind, placebo-controlled, parallel arm pilot study of the effects of the acetylcholinesterase inhibitor, galantamine (vs. placebo), on short-term abstinence among 24 treatment-seeking smokers. The primary outcome is the number of days abstinence a 7 day quit attempt. Secondary outcomes include: smoking rate during the run-up and monitored abstinence phase, medication adherence, side effects, cognitio, and smoking urges and other withdrawal symptons. The pilot data generated will be used to support an NIH grant application by a new investigatot to evaluate whether acetylcholinesterase inhibitors could be effective smoking cessation medications.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smokers ages 18-60, who have smoked at least 10 cigarettes per day for the past 6 months, will be eligible to participate. They must be able to provide informed consent, and express interest in quitting smoking in the next 2 to 6 months. Using a scale from 0 to 100, they must rate their confidence that they will make a quit attempt in the next 6 months a 50 or higher. Following the current study, participants will be referred to a free smoking cessation program in our Center. Those who wish to quit sooner can be referred directly to another program.

Exclusion Criteria:

  • Smoking Behavior

    1. Daily use of chewing tobacco, snuff, and/or snus.
    2. 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 month.
    3. Provide a carbon monoxide (CO) breath sample reading less than 10 parts per million (ppm) at Medical Screening.

      Alcohol/Drugs:

    1. 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.
    2. Current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months.
    3. Providing a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at Intake, Baseline, or Testing Days.
    4. A positive urine drug screen for cocaine, amphetamines, methamphetamines, benzodiazepines, PCP, methadone, barbiturates, and opiates at the Intake, Baseline visit, and Testing days.

      Medical:

    1. 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 and must agree in writing to use an approved method of contraception. Following enrollment, pregnancy tests will be conducted at the Baseline and Testing days for all female subjects of child-bearing potential.
    2. Diagnosis of Alzheimer's Disease or dementia.
    3. Current treatment of cancer or diagnosed with cancer (except basal cell carcinoma) in the past 6 months.
    4. Liver/kidney failure, peptic ulcer disease, benign prostate hypertrophy.
    5. Asthma or chronic obstructive pulmonary disease (COPD).
    6. 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.
    7. Serious or unstable disease within the past 6 months, as determined by the Study Physician/Health Care Provider.
    8. Clinically significant abnormalities within physical examination and vital signs at Intake. Abnormalities will be assessed by the Study Physician/Health Care Provider and eligibility will be determined on a case-by-case basis.
    9. Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.
    10. Uncontrolled high blood pressure (SBP greater than 160 or DBP greater than 100).
    11. Hearing impairment, significant hearing loss (more than 20% in either ear), cochlear implants, or bi-lateral hearing aids.
    12. History of brain injury.
    13. History of epilepsy or a seizure disorder.
    14. Color Blindness.
    15. 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 Intake).

      Psychiatric Exclusion (as determined by self-report on phone screen and/or through MINI during Intake)

    1. 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).
    2. Suicide risk score on MINI greater than 0.
    3. History or current diagnosis of schizophrenia, psychosis, and/or bipolar disorder.
    4. Current or past hypomanic/manic episode.
    5. Current or history of a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD).
    1. 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);
    2. Current use or recent discontinuation (within the last 60 days) of:

      1. Anti-anxiety or panic disorder medications.
      2. Anti-psychotic medications.
      3. Mood-stabilizers (e.g., Lithium, Lamictal/lamotrigine, Neurontin/gabapentin, Topamax/topiramate, valproic acid, Tegretol/carbamazepine).
      4. Anti-depressants (e.g., Wellbutrin, MAOIs, SSRIs, tricyclic antidepressants).
      5. Prescription stimulants (e.g., Provigil, Ritalin, Adderall).
      6. Systemic Steroids (e.g., Prednisone).
      7. Alzheimer's disease medications (e.g., Acetylcholinesterase inhibitors (ACIs), Aricept/donepezil, Exelon/rivastigmine, Tacrine, or memantine).
      8. Parkinson's disease medications(e.g., Cogentin/benztropine).
      9. Irritable bowel syndrome medication (e.g., Dicylomine/Bentyl).
      10. Heart medications (e.g., quinidine or Procardia/nifedipine).
      11. Peptic ulcer disease medication (e.g, Zantac/ranitidine).
      12. Muscle relaxants (e.g., Soma/carisoprodol, Anectine/succinylcholine).
      13. Anti-fungal medication (e.g., Nizoral/ketoconazole).
      14. Anti-seizure medications (e.g., Ativan, Banzel, Carbatrol, Dilantin, Lamictal, Gabitril, Lyrica, Neurontin, Tegretol, Topomax).
      15. COPD medication (e.g., Atrovent/Ipratropium Bromide).
      16. Urinary retention medications (e.g., Duvoid/bethanechol, Proscar/finasteride, Avodart/dutasteride, Dibenzyline/phenoxybenzamine, Regitine/phentolamine).
      17. Eye medication (e.g., Atropine).
    3. Daily use of:

      1. Opiate-containing medications for chronic pain (e.g., Duragesic/fentanyl patches, Percocet, Oxycontin).
      2. Medication for asthma (e.g., albuterol, Serevent, Combivent, Advair, Flovent, Azmacort, Symbicort).
    4. Known allergy to 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 Exclusion

  1. 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.
  2. Not planning to live in the area for the next two months.
  3. 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.
  4. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
  5. 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.
  6. Not able to effectively communicate in English (reading, writing, speaking).
  7. Missing 2 or more consecutive sessions, or 3 or more sessions during the medication period.
  8. Missing 2 or more consecutive doses during the medication period.
  9. Missing 3 or more doses throughout the medication period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845961

Contacts
Contact: Rebecca Ashare, Ph.D 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rebecca Ashare, PhD    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Rebecca Ashare, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01845961     History of Changes
Other Study ID Numbers: UPCC 15912
Study First Received: May 1, 2013
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cholinesterase Inhibitors
Galantamine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014