Trials / Completed
CompletedNCT02448654
Treatment for Nicotine Addiction in Women
COMT Inhibition as a Novel Treatment for Nicotine Addiction in Women
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Yale University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to use a medication tolcapone and or placebo to test if the symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental reasoning in female smokers over a 72 hour period.
Detailed description
The proposed trail will be use a double-blind, placebo-controlled design to conduct the first randomized controlled trial of the COMT inhibitor, tolcapone, in nicotine dependent women. This study will determine if tolcapone is superior to placebo by attenuation the severity of nicotine withdrawal and smoking urges during short-term abstinence. Withdrawal severity will be assessed by a self-report scale and cognitive assessment, including a sustained-attention task. Smoking urges will be assessed by a self-report scale.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolcapone | Tolcapone will be compared to sugar pill |
| DRUG | Sugar Pill | The sugar pill (placebo) will be compared to tolcapone |
Timeline
- Start date
- 2015-10-23
- Primary completion
- 2019-06-30
- Completion
- 2019-06-30
- First posted
- 2015-05-19
- Last updated
- 2020-11-24
- Results posted
- 2020-09-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02448654. Inclusion in this directory is not an endorsement.