N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use

Summary

Tobacco and cannabis co-use is a common and growing public health problem, especially in states that have legalized cannabis. There are no pharmacologic treatments for co-occurring tobacco and cannabis use. Co-use may make quitting either substance more difficult, given the synergistic effects of cannabis and nicotine on neurobiological systems that mediate reward and shared cues reinforcing co-use. N-acetylcysteine (NAC), an FDA-approved medication and over-the-counter supplement, has shown promise in animal studies and randomized controlled trials (RCTs) in reducing tobacco and cannabis craving and use.

Conditions

• Cannabis Use
• Tobacco Use Disorder
• Drug Use Disorder

Interventions

DRUG

N-Acetyl cysteine

The investigators will examine N-acetyl cysteine to treat concurrent tobacco use disorder and cannabis use in a double-blind, placebo-controlled RCT. Eligible regular cigarette smokers with current tobacco use disorder and cannabis use will be randomized to receive NAC 3600 mg per day over 8 weeks.

OTHER

Placebo comparator

The investigators will examine N-acetyl cysteine to treat concurrent tobacco use disorder and cannabis use in a double-blind, placebo-controlled RCT. Eligible regular cigarette smokers with current tobacco use disorder and cannabis use will be randomized to receive placebo per day over 8 weeks.

BEHAVIORAL

Cognitive behavioral therapy (CBT)

Participants in both groups will receive 8 weekly cognitive behavioral therapy sessions for substance use disorder targeting both tobacco and cannabis use.

Sponsors & Collaborators

• Tobacco Related Disease Research Program

  collaborator OTHER

• Ellen Herbst

  lead OTHER

Principal Investigators

• Ellen Herbst, MD · San Francisco Veterans Affairs Medical Center

• Madeline Martinez Rivas, PhD · San Francisco Veterans Affairs Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-25

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Drug

Yes

Countries

• United States

Study Locations