Mobile Contingency Management for Marijuana and Tobacco Cessation

NCT ID: NCT02869451

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-05-17

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.

Detailed Description

Cannabis is the most widely used illicit drug in the United States with 19.8 million current users. Population based data indicate that almost all cannabis users (90%) have a lifetime history of tobacco smoking and the majority (74%) currently smoke tobacco. While cannabis use alone is associated with significant adverse health effects, tobacco smoking is the number one preventable cause of illness and death in the U.S. This is true even among those using illicit drugs where the tobacco -related mortality rate is twice that of the general population. Among cannabis users, smoking tobacco is associated with increased frequency of marijuana use, increased morbidity, and poorer cannabis cessation outcomes. There is strong evidence for the short -term efficacy for cannabis use disorder (CUD) and smoking of contingency management (CM). It is an intensive behavioral therapy that provides incentives (vouchers, money) to individuals misusing substances contingent upon objective evidence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily using clinic based monitoring and effects are short lived. The investigators recently developed a smart -phone application which allows a patient to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server which has made the use of CM for outpatient smoking cessation portable and feasible. The mobile CM (mCM) approach paired with cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective in reducing smoking in the short and long-term. The purpose of this pilot project is to pilot-test a combined cannabis and smoking mCM intervention. The pilot will allow the investigators to examine feasibility of the treatment and of planned recruitment strategies. These project aims will provide the first step toward implementation of an innovative approach that builds upon the power of mHealth technology to reduce the prevalence of both CUD and cigarette smoking.

Conditions

Cigarette Smoking; Marijuana Abuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

bupropion

Intervention Type: DRUG

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

transdermal nicotine patch

Intervention Type: DRUG

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

Nicotine polacrilex

Intervention Type: DRUG

Initiated at smoking quit date.

nicotine lozenge

Intervention Type: DRUG

Initiated at smoking quit date.

counseling for marijuana and smoking cessation

Intervention Type: BEHAVIORAL

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

mobile contingency management

Intervention Type: BEHAVIORAL

treatment that provides money rewards for abstinence from smoking and marijuana

Interventions

bupropion

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

Intervention Type: DRUG

transdermal nicotine patch

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

Intervention Type: DRUG

Nicotine polacrilex

Initiated at smoking quit date.

Intervention Type: DRUG

nicotine lozenge

Initiated at smoking quit date.

Intervention Type: DRUG

counseling for marijuana and smoking cessation

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

Intervention Type: BEHAVIORAL

mobile contingency management

treatment that provides money rewards for abstinence from smoking and marijuana

Intervention Type: BEHAVIORAL

Other Intervention Names

Zyban; nicotine gum; nicorette

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean C Beckham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Pro00072366

Identifier Type: -

Identifier Source: org_study_id