A Study to Help People Quit Smoking.

NCT01880099 | Completed Results DMC

• 2 other identifiers: 13060121541R21DA034815-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.

Conditions

Nicotine Dependence

Keywords

addiction; smoking; tobacco; cigarettes

Outcome Measures

Primary Outcomes (1)

• Smoking Choice Procedure

  After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.

  Data was acquired during a single test session during week 3 of drug intervention.

Study Arms (3)

placebo

PLACEBO COMPARATOR

Placebo (sugar Pill) will be given daily for 7 weeks.

Drug: placebo

galantamine 8mg

ACTIVE COMPARATOR

Galantamine extended release (8mg) will be given daily for 7 weeks.

Drug: Galantamine 8mg

Galantamine 16mg

ACTIVE COMPARATOR

Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.

Drug: Galantamine 16mg

Interventions

placebo DRUG

placebo compared to 8mg of Galantamine

Also known as: sugar pill

placebo

Galantamine 8mg DRUG

8mg of galantamine compared to placebo

Also known as: Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl

galantamine 8mg

Galantamine 16mg DRUG

16mg of galantamine compared to placebo

Also known as: Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl

Galantamine 16mg

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 10 cigarettes daily;
• in good health as verified by medical history, screening examination, and screening laboratory tests;
• 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 GAL allergy;
• requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months);
• serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders;
• abuse of alcohol or any other illicit or prescription drugs;
• use of any other tobacco products, including smokeless tobacco and nicotine products; and
• inability to fulfill all scheduled visits and examination procedures throughout the study period.

Sponsors & Collaborators

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

Study Sites (1)

Veteran Affairs

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Behavior, Addictive; Smoking

Interventions

Sugars; Galantamine; Cholinesterase Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbohydrates; Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Mehmet Sofuoglu, M.D.,Ph.D.
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203-937-4809

Study Officials

• Mehmet Sofuoglu, M.D.,Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 18, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 23, 2020
• Results First Posted: September 25, 2017

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)