NCT02869451

Brief Summary

The purpose of this pilot project is to pilot-test a combined cannabis and smoking cessation treatment. The intervention combines mobile technology with behavioral strategies, counseling, and medications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 9, 2018

Completed
Last Updated

February 7, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

August 8, 2016

Results QC Date

February 5, 2018

Last Update Submit

January 28, 2020

Conditions

Cigarette SmokingMarijuana Abuse

Outcome Measures

Primary Outcomes (4)

  • Number of Participants Who Self-report Prolonged Abstinence From Smoking

    Participants self-report smoking behavior since smoking quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial smoking quit date.

    6 month follow up

  • Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine

    Self-reported abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.

    6 month follow up

  • Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use

    Participants self-report marijuana use since marijuana quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial quit date.

    6 month follow up

  • Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid

    Self-reported abstinence (primary outcome) will be verified by oral fluid (OF) cannabis assessment. Oral fluid samples will be collected from participants who self-report prolonged abstinence.

    6 month follow up

Secondary Outcomes (15)

  • Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking

    6 month follow up

  • Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana

    6 month follow up

  • Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana

    6 month follow up

  • Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking

    6 month follow up

  • Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking

    3 month follow up

  • +10 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.

Drug: bupropionDrug: transdermal nicotine patchDrug: Nicotine polacrilexDrug: nicotine lozengeBehavioral: counseling for marijuana and smoking cessationBehavioral: mobile contingency management

Interventions

bupropionDRUG

Prescribed one week prior to quit and continued until the 6 month follow-up visit.

Also known as: Zyban
Treatment
transdermal nicotine patchDRUG

Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant

Treatment
Nicotine polacrilexDRUG

Initiated at smoking quit date.

Also known as: nicotine gum; nicorette
Treatment
nicotine lozengeDRUG

Initiated at smoking quit date.

Treatment
counseling for marijuana and smoking cessationBEHAVIORAL

5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention

Treatment
mobile contingency managementBEHAVIORAL

treatment that provides money rewards for abstinence from smoking and marijuana

Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • report 40 or more days of cannabis use in the past 90 day;
  • have smoked at least seven cigarettes in the past seven days;
  • have been smoking for at least the past year;
  • can speak and write fluent conversational English;
  • are between 18 and 70 years of age; and
  • are willing to make an attempt to quit both cannabis and tobacco smoking.

You may not qualify if:

  • expected to have unstable medication regimen during the study;
  • currently receiving non-study behavioral treatment for cannabis use disorder or smoking;
  • myocardial infarction in past six months;
  • contraindication to NRT with no medical clearance;
  • use of other forms of nicotine such as cigars, pipes, or chewing tobacco with unwillingness to stop use of these forms;
  • current pregnancy;
  • primary psychotic disorder or current manic episode;
  • substance use disorder (other than cannabis or nicotine) within the preceding three months; or
  • current imprisonment or psychiatric hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

MeSH Terms

Conditions

Cigarette SmokingMarijuana Abuse

Interventions

BupropionTobacco Use Cessation DevicesNicotine Chewing GumCounselingnabiximols

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsTherapeuticsChewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Angela Kirby
Organization
Duke University Medical Center
angela.kirby@duke.edu
919-286-0411

Study Officials

  • Jean C Beckham, Ph.D.

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 17, 2016

Study Start

August 1, 2016

Primary Completion

May 17, 2017

Study Completion

May 17, 2017

Last Updated

February 7, 2020

Results First Posted

April 9, 2018

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)