NCT01880099

Cholinergic Enhancement as a Treatment for Nicotine Addiction

Completed NA Results posted Last updated 4 March 2020

What this trial tests

NA trial testing placebo in Nicotine Dependence in 60 participants. Completed in 1 December 2015.

Timeline

1 December 2013

Primary endpoint
1 December 2015

1 December 2015

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 December 2013
Primary completion	1 December 2015
Estimated completion	1 December 2015
Sites	1 location across United States

Drugs / interventions tested

• placebo
• Galantamine 8mg — full drug profile →
• Galantamine 16mg — full drug profile →

Conditions studied

• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

Yale University

Who can join

Adults 18 to 55, any sex, with Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.