Galantamine Effects on Nicotine Responses in Smokers

NCT01417429 | Completed Phase 1 DMC

• 2 other identifiers: HIC1001006227NCT01417429
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will first have two 4-day treatment periods, in which they will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. During the first 3-days of each treatment period, smokers will have daily clinic visits, where they will receive study medications and any adverse effects from study medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period, subjects will refrain from smoking for approximately 2.5 days, until the experimental session on Day 4. Compliance with non-smoking will be verified by CO levels \< 10 ppm. During the experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced among subjects such that equal number of subjects will receive saline first or nicotine first. Following each saline and nicotine treatments, physiological, subjective and cognitive measurements will be obtained

Conditions

Smoking; Tobacco Withdrawal

Keywords

galantamine; subjective nicotine; tobacco withdrawal symptoms; nicotine

Outcome Measures

Primary Outcomes (1)

• Galantamine Effects on Nicotine Responses in Smokers

  Urine sample and blood samples anticipated for 24 male and females

  1 year to complete

Study Arms (2)

Galantamine

ACTIVE COMPARATOR

galantamine will be given with intravenous nicotine

Drug: Galantamine

Nicotine

EXPERIMENTAL

Subject will be given IV Nicotine

Drug: IV Nicotine

Interventions

Galantamine DRUG

8mg/a day or placebo

Also known as: Razadyne, Razadyne ER

Galantamine

IV Nicotine DRUG

1.0 mg/70 kg of nicotine against saline

Also known as: liquid nicotine

Nicotine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female and male smokers, aged 18 to 55 years;
• history of smoking daily for the past 12 months, at least 15 cigarettes daily;
• CO level \> 10ppm;
• for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

You may not qualify if:

• history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
• regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and/or recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year;
• current dependence on alcohol or on drugs or treatments for drug or alcohol addiction ;
• use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
• known allergy to galantamine

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Department of Veterans Affairs

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Galantamine; Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Solanaceous Alkaloids; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mehmet Sofuoglu, M.D.,Ph.d.

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: August 16, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

US (1)