Effect of Galantamine on Short-term Abstinence

NCT01669538 | Completed Phase 2 Results

• 3 other identifiers: 815789UPCC15912K23DA035295
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Disorder

Keywords

Galantamine; Nicotine Bitartrate; Nicotine Tartrate; Nicotine dependence; Tobacco Dependence

Outcome Measures

Primary Outcomes (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.

  Days 17-23

Secondary Outcomes (3)

• Cognitive Performance

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

• Subjective Symptoms

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

• Common Side Effects of Galantamine Check List

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

Study Arms (2)

Galantamine

EXPERIMENTAL

Galantamine 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.

Drug: Galantamine

Placebo

PLACEBO COMPARATOR

Participants 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.

Drug: Placebo

Interventions

Galantamine DRUG

Also known as: Galantamine hydrobromide ER, Razadyne ER

Galantamine

Placebo DRUG

Also known as: Sugar pill

Placebo

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.
• 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).

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 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.
• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• National Center for Research Resources (NCRR): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Galantamine; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rebecca Ashare
• Organization: University of Pennsylvania

rlashare@pennmedicine.upenn.edu

2157465789

Study Officials

• Rebecca Ashare, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 21, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-01

Locations

US (1)