The Pharmaceutically Enhanced Reinforcement for Reduced Alcohol and Smoking (PERRAS) Study: Protocol for a randomized...

Area of Science:

• Addiction medicine
• Clinical psychology
• Neuroscience

Background:

• Co-use of alcohol and tobacco leads to significant morbidity and mortality.
• Integrated treatment approaches may effectively reduce the use of both substances.
• No current guidelines exist for treating co-addiction to alcohol and tobacco.

Purpose of the Study:

• To evaluate the effectiveness of combining Contingency Management (CM) for Alcohol Use Disorder (AUD) with Varenicline for smoking cessation.
• To reduce alcohol and tobacco use in individuals with AUD who smoke and seek treatment.
• To evaluate the mediator effect of Addiction Neuroclinical Assessment (ANA) domains on treatment outcomes.

Main Methods:

• 205 participants with AUD who smoke were randomized into two 12-week conditions: CM + Varenicline or Non-Contingent (NC) + Varenicline.
• CM group received rewards contingent on negative alcohol samples; NC group received rewards independent of alcohol positivity.
• Primary outcomes measured objective verification of abstinence thrice-weekly during the intervention, with follow-ups at 1, 3, and 6 months.

Main Results:

• The study is designed to demonstrate the efficacy of the integrated treatment approach.
• Objective verification of abstinence during the 12-week intervention phase is the primary outcome.
• Follow-up evaluations will assess sustained abstinence at 1, 3, and 6 months post-intervention.

Conclusions:

• An integrated treatment combining CM for AUD and Varenicline shows potential for significant health benefits.
• This approach may help identify how ANA-based responses influence treatment outcomes.
• Efficacious treatment is crucial for a prevalent population with co-occurring alcohol and tobacco use disorders.