Effect of Galantamine on Smoking Abstinence

NCT01548638 | Completed Phase 2 Results

• 1 other identifier: 814947
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a preliminary open-label study to determine 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.

Conditions

Nicotine Addiction

Keywords

Tobacco; Smoking; Galantamine

Outcome Measures

Primary Outcomes (1)

• Number of Days of Abstinence During a 7-day Quit Attempt

  Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.

  Days 36-43; following a 5-week dose run-up

Secondary Outcomes (6)

• Cognitive Performance: Working Memory Reaction Time

  At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43

• Cognitive Performance: Working Memory Accuracy

  At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43

• Subjective Symptoms (Smoking Urges)

  Days 7, 14, 21, 28, 35, and 43; Baseline session

• Side Effects of Galantamine

  Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline session

• Subjective Symptoms (Negative Affect)

  Days 7, 14, 21, 28, 35, and 43; Baseline session

Study Arms (1)

Galantamine ER

EXPERIMENTAL

The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.

Drug: Galantamine ER

Interventions

Galantamine ER DRUG

The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily. Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.

Also known as: Razadyne ER

Galantamine ER

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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 Health Insurance Portability and Accountability Act (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).

You may not qualify if:

• 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 10ppm at Medical Screening or Baseline visit.
• Alcohol/Drugs
• Lifetime history of substance abuse (other than nicotine) and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, stimulants, Phencyclidine (PCP), benzodiazepines, or study prohibited medications/recreational drugs) as determined by self-report during the phone screen and/or through the MINI during the Medical Screening.
• 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 Medical Screen or Baseline sessions.
• A positive urine drug screen for cocaine, amphetamines, methamphetamines, benzodiazepines, PCP, methadone, barbiturates, and opiates at the Medical Screening, Baseline visit, and Testing days.
• Medical
• Women who are pregnant, planning a pregnancy in the next 3 months, or lactating; all female subjects of child-bearing potential shall undergo a urine pregnancy test prior to enrollment and must agree in writing to use an approved method of contraception. Pregnancy tests will be conducted at the Medical Screening, Baseline visit, and Testing days.
• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, School of Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Center for Interdisciplinary Research on Nicotine Addiction homepage

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Rebecca Ashare
• Organization: University of Pennsylvania Perelman School of Medicine

rlashare@mail.med.upenn.edu

2157465789

Study Officials

• Rebecca Ashare, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 8, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2013
• Last Updated: December 26, 2017
• Results First Posted: July 2, 2014

Record last verified: 2017-11

Locations

US (1)