N/A
Completed N=36
Treatment for Nicotine Addiction in Women
Source: ClinicalTrials.gov NCT02448654 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Withdrawal Symptoms (MNWS Score) — 13.33; 9.40; 11.95; 13.29 score on a scale — p=0.18
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Withdrawal Symptoms (MNWS Score) |
13.33; 9.40; 11.95; 13.29 | 0.18 |
| PRIMARY Smoking Urges (BQSU Factor 1) |
19.69; 13.42; 14.50; 16.04 | 0.03 sig |
| PRIMARY Smoking Choice Paradigm: Amount Earned ($) |
7.41; 7.06 | 0.037 sig |
Eligibility Criteria
Inclusion Criteria
- Must be 18yrs to 45yr old woman, read and write in English.
- Must smoke at least 5 or more cigarettes a day
- FTND score at least 4 or higher
- A CO reading of 10 or higher during screening
- Must be in good health as verified by medical history, screening exam, screen laboratory tests.
Exclusion Criteria
- Excluded if using psychotropic medications, have contraindications to tolcapone use (e.g.. liver problems, allergy to tolcapone, history of no traumatic rhabdomyolysis or hyperpyrexia, confusion possibly related to medication), have other substance use disorder, are pregnant or breast feeding, have a current psychotic disorder, bipolar disorder, homicidal or suicidal ideation, have current (past month) substance use disorder, other than nicotine dependence, or are unable to fulfill the scheduled visits and procedures.
Data sourced from ClinicalTrials.gov (NCT02448654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.