Phase 4
Completed N=45
Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking
Smoking Cessation · Alcohol Drinking
Source: ClinicalTrials.gov NCT02995915 ↗
Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants Who Self-report Prolonged Abstinence From Smoking — 3; 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. The purpose of this research study is to develop an intervention designed to help people stop drinking alcohol and stop smoking at the same time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Self-report Prolonged Abstinence From Smoking |
7; 0 | — |
| PRIMARY Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified |
2; 0 | — |
| PRIMARY Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use |
13; 1 | — |
| PRIMARY Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified |
13; 1 | — |
| PRIMARY Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol |
1; 0 | — |
| PRIMARY Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified |
1; 0 | — |
| SECONDARY Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking |
13; 9 | — |
| SECONDARY Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking |
5; 1 | — |
| SECONDARY Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use |
-9.67; -10.3 | — |
| SECONDARY Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use |
-7.53; -13.9 | — |
| SECONDARY Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use |
-9.22; -11.00 | — |
| SECONDARY Number of Participants Who Are Able to Achieve Recommended Drinking Limits (i.e., Less Than or Equal to 14 Drinks Per Week and Fewer Than 5 Drinks Per Day for Men; Less Than or Equal to 7 Days Per Week and Less Than 4 Drinks Per Day for Women) |
16; 8 | — |
| SECONDARY Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use |
13; 1 | — |
| SECONDARY Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified |
13; 1 | — |
| SECONDARY Change in Number of Average Cigarettes Smoked Per Day |
-8.56; -5.30 | — |
| SECONDARY Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use |
-9.22; -4.70 | — |
| SECONDARY Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking |
13; 9 | — |
| SECONDARY Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking |
13; 9 | — |
| SECONDARY Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use |
13; 1 | — |
| SECONDARY Number of Participants Who Self-report Prolonged Abstinence From Smoking |
7; 0 | — |
| SECONDARY Number of Participants Who Self-report Prolonged Abstinence From Smoking |
7; 0 | — |
| SECONDARY Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking |
5; 2 | — |
| SECONDARY Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking |
5; 2 | — |
| SECONDARY Number of Smoking Quit Attempts |
2.29; 1.00 | — |
| SECONDARY Number of Smoking Quit Attempts |
2.29; 1.00 | — |
| SECONDARY Number of Smoking Quit Attempts |
2.29; 1.00 | — |
Eligibility Criteria
Inclusion Criteria
- currently meet criteria for DSM-5 mild to moderate alcohol use disorder (meeting 2-5 criteria for AUD)
- have been engaging in hazardous drinking over the past month, defined as either exceeding a mean of 14 standard drinks/wk for men, 7 drinks/wk for women; or by consuming >5 on at least one occasion in the last month for men, >4 drinks on at least one occasion in the last month for women
- currently smoke >10 cigarettes a day, and have smoked for at least one year
- can speak and write fluent conversational English
- are willing to make an attempt to quit both alcohol and smoking
Exclusion Criteria
- are expected to have unstable medication regimen during the study
- are currently receiving non-study behavioral treatment for alcohol use disorder or smoking
- have severe alcohol use disorder (meeting >6 criteria for AUD or having alcohol withdrawal symptom criterion)
- have AUD that is in early remission, with no symptoms evident over the past month
- have experienced myocardial infarction in past 6 months
- contraindication to nicotine replacement therapy with no medical clearance to participate in the study
- use other forms of nicotine such as cigars, pipes, or chewing tobacco
- are currently pregnant
- have a primary psychotic disorder or current manic episode
- have had substance use disorder (other than alcohol or nicotine) in the preceding 3 months
- are currently imprisoned or in psychiatric hospitalization
Data sourced from ClinicalTrials.gov (NCT02995915). 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.