A Study to Help People Quit Smoking.

March 4, 2020 updated by: Yale University

Cholinergic Enhancement as a Treatment for Nicotine Addiction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We propose a double-blind, placebo-controlled, outpatient study with a between-groups design. Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to the target doses over a 2-week period (Table 2). During Week 3, following overnight abstinence from smoking, participants will present for a laboratory Test Session in which they will have the option of cigarette self-administration. After this Test Session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. Smokers will establish a quit date at the beginning of this Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will administer EMA assessments. The study medication will be tapered after the end of Week 4 of the Treatment Phase. Participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Veteran Affairs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Placebo (sugar Pill) will be given daily for 7 weeks.
Drug: placebo
placebo compared to 8mg of Galantamine
Other Names:
  • sugar pill
Active Comparator: galantamine 8mg
Galantamine extended release (8mg) will be given daily for 7 weeks.
Drug: Galantamine 8mg
8mg of galantamine compared to placebo
Other Names:
  • Acetylcholinesterase inhibitors, Galantamine ER,
  • Razadyne, Razadyne ER, Reminyl
Active Comparator: Galantamine 16mg
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
16mg of galantamine compared to placebo
Other Names:
  • Acetylcholinesterase inhibitors, Galantamine ER,
  • Razadyne, Razadyne ER, Reminyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Choice Procedure
Time Frame: Data was acquired during a single test session during week 3 of drug intervention.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1306012154
  • 1R21DA034815-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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