NCT03734666

Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation

Completed NA Results posted Last updated 15 January 2026

What this trial tests

NA trial testing Mindfulness Based Relapse Prevention - Smoking and Alcohol in Tobacco Use in 67 participants. Completed in 4 November 2021.

Timeline

14 January 2019

Primary endpoint
4 November 2021

4 November 2021

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	67
Start date	14 January 2019
Primary completion	4 November 2021
Estimated completion	4 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness Based Relapse Prevention - Smoking and Alcohol
• Cognitive Behavioral Therapy

Conditions studied

• Tobacco Use — all drugs for Tobacco Use →
• Alcohol Use, Unspecified — all drugs for Alcohol Use, Unspecified →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Tobacco Use or Alcohol Use, Unspecified. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Aim 2: Number of Participants Scoring >3 Primary · End of Treatment at 8 Weeks

Number of participants scoring \>3. Patient satisfaction will be determined through a score on the Client Satisfaction Questionnaire Version 8 (Attkinson \& Greenfield), where participants respond to 8 items on a 4-point scale (1=very dissatisfied; 4=very satisfied). Results reported indicate clients with a patient satisfaction score over 80%.

Group	Value	95% CI
Mindfulness Based Relapse Prevention	18
Cognitive Behavioral Therapy	16

Aim 2: Rate of Recruitment of Eligible Participants Primary · 20 weeks

Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week

Group	Value	95% CI
Eligilible Recruited Participants	6

Aim 2: Participant Retention Primary · End of study at Week 16 Follow-up

Percentage of participants retained through follow-up

Group	Value	95% CI
Mindfulness Based Relapse Prevention	46
Cognitive Behavioral Therapy	50

Aim 2: Percentage of Participants That Completed Questionnaires Primary · End of study at Week 16 Follow-up

Percentage of participants who completed questionnaires at week 16

Group	Value	95% CI
Mindfulness Based Relapse Prevention	34.7
Cognitive Behavioral Therapy	31.4

Aim 3: Percent of Smoking Abstinence End of Treatment Secondary · End of Treatment at 8 Weeks

Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.

Group	Value	95% CI
Mindfulness Based Relapse Prevention	34.3
Cognitive Behavioral Therapy	31.3

Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up Secondary · At 16 week follow-up

Percent of smoking abstinence, measured by biochemical verification of abstinence via saliva continine and self-report of no smoking in the past 7 days. Participants who report abstinence will be mailed a saliva continine kit to confirm abstinence at their 16 week follow up call.

Group	Value	95% CI
Mindfulness Based Relapse Prevention	14.3
Cognitive Behavioral Therapy	3.1

Aim 3: Percent of Heavy Alcohol Use at End of Treatment Secondary · End of Treatment at 8 Weeks

Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.

Group	Value	95% CI
Mindfulness Based Relapse Prevention	4	0 – 100
Cognitive Behavioral Therapy	6.3	0 – 100

Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up Secondary · At 16 week follow-up

Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.

Group	Value	95% CI
Mindfulness Based Relapse Prevention	5.1	0 – 100
Cognitive Behavioral Therapy	4.6	0 – 100

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness Based Relapse Prevention

Serious: 1/35 (3%)

Deaths: 0/35

Cognitive Behavioral Therapy

Serious: 3/32 (9%)

Deaths: 0/32

Serious adverse events (5 terms)

Reaction	System	Mindfulness Based Relapse …	Cognitive Behavioral Therapy
General Disorders and administration site conditions - Other	General disorders	—	—
Renal calculi	Renal and urinary disorders	—	—
Torn Ligament	Musculoskeletal and connective tissue disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Flu like symptoms	General disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Mindfulness Based Relapse …	Cognitive Behavioral Therapy
Pain	General disorders	—	—

Most-reported serious reactions: General Disorders and administration site conditions - Other, Renal calculi, Torn Ligament, Fall, Flu like symptoms.

Data from ClinicalTrials.gov NCT03734666 adverse events section.

Sponsor's own description

The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mindfulness-based interventions for substance use disorders.
   Goldberg SB, Pace B, Griskaitis M, Willutzki R, et al · · 2021 · cited 21× · PMID 34668188 · DOI 10.1002/14651858.cd011723.pub2
2. Transition to telehealth: Challenges and benefits of conducting group-based smoking and alcohol treatment virtually.
   Vinci C, Hemenway M, Baban SS, Yang MJ, et al · · 2022 · cited 10× · PMID 35085833 · DOI 10.1016/j.cct.2022.106689
3. Meditation for the primary and secondary prevention of cardiovascular disease.
   Rees K, Takeda A, Court R, Kudrna L, et al · · 2024 · cited 5× · PMID 38358047 · DOI 10.1002/14651858.cd013358.pub2
4. Pilot randomized controlled trial of mindfulness-based relapse prevention vs cognitive behavioral therapy for smoking and alcohol use.
   Vinci C, Sutton SK, Yang MJ, Baban S, et al · · 2023 · cited 5× · PMID 36645978 · DOI 10.1016/j.drugalcdep.2023.109768
5. What Happens When You Smoke a Cigarette Mindfully? A Deductive Qualitative Study.
   Yang MJ, Ketcher D, Witkiewitz K, Unrod M, et al · · 2022 · PMID 37692535 · DOI 10.1007/s12671-022-01984-7