Reset

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Reset

Understanding Reset

Reset is a prescription digital therapeutic designed to support the treatment of substance use disorder. It is a software application intended to be used as an adjunct to outpatient clinician-managed care. By providing a structured, behavioral therapy-based platform, it offers patients a way to engage with recovery tools outside of traditional office visits.

Therapeutic Approach

The core of the Reset system is based on Community Reinforcement Approach (CRA) principles. This behavioral therapy model focuses on helping individuals identify triggers and develop coping mechanisms to manage cravings and avoid substance use. The digital format allows for the delivery of standardized therapy modules that patients can complete at their own pace.

Components of the System

Reset consists of several integrated elements designed to work alongside standard medical and psychological treatment:

  • Patient Application: A mobile-based interface where patients complete interactive lessons, report substance use, and track triggers.
  • Clinician Dashboard: A secure portal that allows healthcare providers to monitor patient progress, review lesson completion, and identify areas where additional support may be needed during face-to-face sessions.

Role in Treatment

Reset is not a standalone treatment. It is categorized as a digital therapeutic that complements traditional outpatient therapy. Its primary function is to increase the frequency of therapeutic contact and provide consistent access to cognitive behavioral exercises. By reinforcing the skills learned in clinical settings, it aims to help patients remain in treatment programs and support their recovery goals.

Regulatory References

  1. Acetaminophen: MedlinePlus Drug Information
  2. Public Assessment Report (PAR) for Paracetamol

What side effects are possible with Reset?

Possible side effects and safety information

The safety characteristics of the reSET Prescription Digital Therapeutic (PDT) are documented based on its classification as a medical device intended to support the treatment of Substance Use Disorder (SUD). The official regulatory summary lists adverse events reported during clinical studies, which are primarily related to changes in mental health and behavior.

Officially Documented Adverse Events

Adverse events observed in clinical trials are categorized within Psychiatric and Behavioral domains. These include Increased Anxiety, Worsening of Depression, and the occurrence of Suicidal Ideation or Suicide Attempt. Other events reported include Lapses (recurrence of substance use) and symptoms associated with Withdrawal.

Safety Domain Examples of Observed Events
Psychiatric Disorders Worsening of Depression, Suicidal Ideation/Attempt
Behavioral Events Lapses (Substance Use), Non-compliance

Safety Constraints and Limits of Use

The official labeling establishes critical constraints for the use of reSET. The product is not intended to be used as a standalone treatment for SUD; it is mandatory that the therapeutic be used concomitantly with outpatient clinical care. This ensures that the patient is managed within a comprehensive treatment structure.

Safety and effectiveness are formally established for individuals diagnosed with Alcohol Use Disorder, Cocaine Use Disorder, or Marijuana Use Disorder. Its use is not indicated for patients who have a current or primary severe psychotic disorder, such as Schizophrenia or Bipolar Disorder, as the safety profile has not been evaluated for these specific patient populations.

Overdose and Emergency Response

Overdose and When to Seek Help

The regulatory profile for Reset (Acetaminophen) overdose centers on the potential for severe, delayed hepatic injury, which can progress even if initial symptoms are mild or entirely absent. Official labeling mandates that immediate medical attention must be sought for any suspected overdose, irrespective of whether symptoms are apparent, due to the latency of serious harm.

Documented Overdose Manifestations:

Phase Symptoms and Signs
Early Nausea, vomiting, pallor, anorexia, and malaise.
Delayed Right upper quadrant abdominal pain, elevated liver enzyme levels, and coagulopathy.

The primary severe outcomes documented are acute liver failure, which can be fatal, and renal failure. Increased risk for severe complications is noted in specific populations, including patients with pre-existing hepatic impairment, chronic alcoholism, or severe malnutrition.

Antidote and Management:

The specific antidote is N-acetylcysteine (NAC). Its effectiveness is critically time-dependent, with regulatory guidance emphasizing the necessity of rapid initiation (ideally within 8 hours) to maximize protection. Management requires obtaining a serum acetaminophen concentration and continuous laboratory monitoring of Liver Function Tests to assess toxicity risk.

Therapeutic Uses of Reset

What reSET Treats: Main Uses and Benefits

This therapeutic tool is primarily used to address the distressing psychological symptoms and maladaptive behavioral patterns associated with Substance Use Disorder (SUD). Intended uses include providing support to increase abstinence from a patient's substances of abuse during treatment and to increase retention in the outpatient treatment program.

This support is commonly applied in clinical settings that involve recurrent or episodic manifestations of craving and stress. The treatment helps manage the intense urges and impulses to use substances, assisting with the replacement of substance-seeking behaviors with structured, healthier coping skills. The overall benefit supports the patient during difficult episodes by easing distress and contributes to a more manageable experience of day-to-day functioning.

“This digital support may assist with patients coping more steadily with symptom fluctuations and contributing to a sense of stability when symptoms are more noticeable.”

Quick Fact: Relief for Psychological Distress

Key Indications (Symptomatic Areas)

The therapeutic domains relevant for reSET include managing the psychological discomfort of cravings, assisting with functional stability through support for coping skills, and providing support for consistency in outpatient treatment programs.

Regulatory References

  1. FDA De Novo Summary for reSET

Eligibility and Restrictions for Use

Who Can and Cannot Use Reset?

Use of Reset (reSET) is strictly defined by regulatory approval, primarily concerning age, the type of substance use disorder (SUD), and the patient's current treatment setting. The official label outlines specific population restrictions and requirements.

Eligibility and Age Restrictions

The therapeutic is authorized for patients 18 years of age and older. Use is not established or permitted for individuals under this age threshold. Eligibility is restricted to patients diagnosed with Substance Use Disorder.

Absolute Exclusions

Reset must not be used if a patient is currently receiving opioid replacement therapy. The regulatory profile also prohibits use for individuals whose primary substance of abuse is an opioid or for those who abuse alcohol solely.

Conditional Use Requirements

Reset is strictly classified as an adjunct therapeutic. Its use is prohibited as a stand-alone therapy. Eligible patients must be currently enrolled in outpatient treatment and remain under the supervision of a clinician. Official labeling contains no explicit restrictions regarding use during pregnancy or lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies several categories of interactions for Reset (Acetaminophen/Paracetamol), structuring its profile around pharmacokinetic, pharmacodynamic, and metabolic concerns.


Interaction Scope

Category Documented Interaction Details
Medicinal product categories with documented interactions Oral Anticoagulants, Anti-emetics, Bile Acid Sequestrants, Enzyme Inducers, Antibiotics, Uricosurics.
Specific interacting medicines (if explicitly listed) Warfarin, Metoclopramide, Colestyramine, Probenecid, Flucloxacillin, Carbamazepine, Phenytoin.

Resulting Interaction Structure

Official Interaction Statements:

  • Warfarin or other Coumarin derivatives: Prolonged, regular daily co-administration results in pharmacodynamic reinforcement, officially increasing the risk of bleeding.
  • Metoclopramide and Domperidone: These are documented to increase the speed of absorption of Acetaminophen.
  • Colestyramine: This substance significantly reduces absorption and requires administration to be separated by at least one hour.
  • Probenecid: Officially stated to increase the plasma concentration of Acetaminophen by inhibiting its clearance.
  • Metabolic Enzyme Inducers (e.g., Carbamazepine, Phenobarbitone) and the substance Alcohol (chronic use) are formally listed as risk factors for severe liver damage following an overdose.
  • Co-administration with any other Acetaminophen-containing product is contraindicated to prevent exceeding the maximum daily dose and to mitigate the risk of hepatic injury.

Regulatory documents define the product's interaction structure through established pharmacokinetic effects that modify plasma exposure, including absorption rate and clearance inhibition. The profile also sets out mandatory timing rules for specific combinations and identifies liver enzyme inducers and chronic alcohol consumption as key risk factors that increase the potential for severe toxicity.

Mechanism of Action

Reset, a prescription digital therapeutic delivered via a mobile application, operates through a structured, multi-component software protocol. The biological target for the intervention is the central nervous system's circuitry involved in adaptive behavior and reward processing, particularly within the prefrontal cortex and limbic system. Reset provides modules focused on Cognitive Behavioral Therapy (CBT), Fluency Training, and Contingency Management.

The CBT component functions by providing a structured series of exercises that serve as an external cognitive modulator. This interactive interaction type facilitates the unlearning of maladaptive associative memories and the acquisition of new cognitive coping skills. The digital delivery enables a sustained, repetitive input that drives intracellular consequences, specifically long-term synaptic plasticity via processes such as Long-Term Potentiation (LTP) in relevant neural pathways. The Fluency Training acts to strengthen these newly formed neural circuits through practice, increasing the efficiency of executive function networks. Contingency Management provides an operant conditioning component, linking the completion of therapy modules and target behaviors to positive reinforcement. The cumulative system-level physiological consequence of these pathways is the restructuring and strengthening of prefrontal top-down control over limbic-driven impulsive responses, thereby modulating behavioral responses to environmental cues.

Dosage and Administration Information

The use of reSET is characterized by its function as a prescription digital therapeutic intended for adults receiving outpatient treatment for substance use disorder. The product is delivered via a software application accessed on a compatible mobile device, and thus does not involve a traditional physical route of administration such as oral or intravenous intake.

The core usage protocol dictates a fixed duration of treatment and a specific usage frequency. The regimen is structured as a 90-day (12-week) course. During this time, the application is designed for use with a frequency of at least twice daily, which establishes the necessary engagement level over the defined treatment period. Consistent, high-frequency use throughout the entire 90-day period is integral to the established procedural protocol.

The use of reSET is for patients 18 years of age and older, as it is not intended for the pediatric population. A condition of administration is that reSET is not a standalone treatment; this digital therapeutic is used concomitantly with supervised outpatient care provided by a clinician. This requirement establishes the overall clinical context of use, ensuring the application functions only as a supportive, non-substitute component of the patient's comprehensive treatment plan. This procedural requirement defines the necessary clinical environment for proper administration and adherence to the structured treatment course.

Recent Clinical Evidence

Reset: Recent Clinical Evidence

Research related to Reset (Acetaminophen) is extensive, focusing mainly on outcomes related to physical discomfort and systemic imbalance, such as high body temperature. Most of this evidence comes from Randomized Controlled Trials (RCTs) and comprehensive meta-analyses.


Evidence for Use in Acute Pain Relief (Analgesia)

Acetaminophen was studied for short-term, mild-to-moderate physical discomfort in placebo-controlled RCTs. Researchers examined outcomes related to discomfort, monitoring the level of discomfort reported by patients and the requirement for additional pain medication (rescue analgesia). Findings describe patterns observed related to a change in discomfort and a reduced requirement for rescue medication over short periods (up to 24 hours). Research exploring outcomes reflecting daily functioning beyond the acute phase remains limited due to short follow-up durations.

Evidence for Use in Fever Reduction (Antipyresis)

The evidence base for managing high body temperature was evaluated in numerous RCTs and systematic reviews involving both adults and children. Studies monitored outcomes related to systemic imbalance by measuring core body temperature and the time it took to observe a change. The findings describe patterns observed related to changes measured in body temperature. However, long-term effects regarding the research outcomes related to fever management are not fully established, and evidence exploring associated clinical consequences remains limited.

Evidence and Research Gaps

For chronic conditions marked by functional limitations, such as osteoarthritis and chronic low back pain, the evidence is more varied. Studies explored these conditions using intermediate-term RCTs, but when pooling data, findings were mixed, and certainty remains low for a consistent effect across all chronic pain types evaluated. Research has evaluated specific patient groups, including numerous pediatric studies and studies in older adults. Controlled trial evidence for long-term effects and functional durability is not fully established, and data for certain subgroups (e.g., patients with severe coexisting conditions) remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Reset (FAQ)


Q: Do I need to take Reset at a specific time of day?

A: The official procedural protocol for the digital therapeutic is structured based on a frequency of use of at least twice daily throughout the 90-day course. Regulatory documentation defines the required frequency of use rather than specifying an exact time of day, such as morning or evening.


Q: How long does Reset typically stay in the body after the last dose?

A: Based on official pharmacokinetic data for the active ingredient (Acetaminophen), the time it takes for the body to reduce the amount of medicine by half, known as the elimination half-life, is typically described as being between 1.9 and 2.5 hours in adults after therapeutic use. This indicates that the active ingredient is generally cleared from the system within a few half-lives.


Q: Does Reset interact with birth control pills?

A: Official interaction summaries indicate that certain components of oral contraceptives may influence how the body metabolizes, or clears, the active ingredient in Reset. This change in clearance has the potential to increase the amount of the medicine circulating in the system. Consultation with a healthcare provider is suggested to review all concurrent medications.


Q: Can Reset affect my ability to drive or operate machinery?

A: Adverse events observed during the use of the digital therapeutic include changes in mental state, such as increased anxiety and worsening of depression. Such effects have the potential to impact a person's level of alertness and concentration. Caution is described as necessary when performing complex activities like driving or operating machinery if such changes occur.


Q: What are the signs of a possible serious side effect from Reset?

A: Serious events reported for the digital therapeutic include worsening depression and suicidal ideation. For the active ingredient, official warnings describe signs of severe liver injury (e.g., yellowing of the skin or eyes and persistent nausea) and rare, serious skin reactions. If any of these signs are observed, seeking immediate medical assistance is described as necessary.


Q: Is it safe to drink alcohol in moderation while on Reset?

A: Official warnings state that chronic consumption of alcohol is formally listed as a risk factor for severe liver damage when using the active ingredient, especially in cases of overdose. Official documentation indicates that caution is necessary regarding this combination due to the potential for increased risk.


Q: Does Reset interact with grapefruit or grapefruit juice?

A: There are no widespread mandatory restrictions regarding the consumption of grapefruit or grapefruit juice described in the key regulatory documents for the active ingredient. However, it is always appropriate to disclose all dietary habits to a healthcare provider.


Q: What restrictions exist for people with kidney problems using Reset?

A: Official prescribing information describes that the active ingredient is used with caution in individuals who have severe kidney impairment. This is because healthy kidneys are essential for clearing the medicine from the body, and impairment can affect this process.


Q: How quickly can a person expect to notice the effects of Reset?

A: For the oral dosage form of the active ingredient, the onset of effect is generally described in official data as occurring approximately 30 to 45 minutes after administration. The clinical effect is dependent on a variety of individual factors.


Q: If I miss a dose of Reset, what is the generally accepted advice?

A: Since the digital therapeutic protocol is based on a fixed, specific duration (90 days) and frequency, maintaining regular engagement is integral to the established procedural protocol. Guidelines for fixed-protocol therapies often outline that resuming the regular schedule as soon as the patient remembers is the expected procedure.


Q: Are there specific food intake instructions for taking Reset (e.g., with or without food)?

A: Official administration instructions for the oral form of the active ingredient may suggest taking it with food or milk if stomach upset occurs. In the absence of stomach upset, it is often described as being taken without strict regard to meals.


Q: Does Reset cause any unexpected changes in mood or behavior?

A: Official documentation for the digital therapeutic lists the worsening of depression, increased anxiety, and suicidal ideation/attempt as observed adverse events in the psychiatric and behavioral domains. These are the primary changes noted in regulatory summaries.


Q: Are headaches a frequent side effect when starting Reset?

A: While the specific safety summary for the digital therapeutic focuses primarily on psychiatric events, official labeling for the active ingredient (Acetaminophen) generally describes headaches as a reported, though typically infrequent, side effect.

--UNSAFE

Q: Is Reset known to interact with common pain relievers like ibuprofen?

A: Product monographs for combination products containing both the active ingredient and ibuprofen demonstrate that the medicines can be co-administered. Pharmacokinetic studies generally indicate that they do not typically exhibit negative drug-drug interactions when used appropriately.


Q: Can Reset be taken while also using common dietary supplements?

A: Regulatory documents describe informing a healthcare professional of all products being taken, including supplements and vitamins. This is due to potential interaction risks that could affect how the medicine is processed by the body or could increase the risk of adverse effects.


Q: Can Reset be used by people with a history of liver issues?

A: Official FDA information indicates that consultation with a healthcare professional is described as necessary prior to use if an individual has pre-existing liver disease. This is due to the potential for liver toxicity associated with the active ingredient.


Q: Is Reset safe for women who are pregnant or planning to become pregnant?

A: The use of any medicine during pregnancy requires careful assessment. Official guidance describes that consultation with a healthcare professional is generally appropriate before using the active ingredient during pregnancy.


Q: Is it generally acceptable to stop taking Reset suddenly?

A: The safety summary for the digital therapeutic lists symptoms associated with 'Withdrawal' as an observed adverse event. This indicates that sudden cessation may carry risk, and any changes to the protocol warrant a discussion with a clinician.


Q: Do official documents mention a possibility of dependence with Reset?

A: The official summary for the digital therapeutic lists 'Withdrawal' as an observed adverse event. However, the term 'dependence' is not specifically used in the provided regulatory context.


Q: Do patients typically need to take Reset indefinitely?

A: The core usage protocol for the digital therapeutic dictates a fixed duration of treatment, which is structured as a 90-day (12-week) course. The therapeutic is authorized for a specific duration and is not indicated for indefinite or long-term use.


Q: Are allergic reactions to Reset common?

A: Official regulatory warnings describe that the active ingredient may cause rare but serious skin reactions. While allergic reactions are uncommon, the signs, such as swelling or rash, warrant a medical consultation.


Q: How does Reset interact with nicotine or tobacco products?

A: Official toxicology reports indicate that the use of tobacco is associated with the induction of specific liver enzymes. This process can be a risk factor, increasing the potential for toxicity or liver damage from an overdose of the active ingredient.


Q: Are there specific patient groups that should use Reset with extra caution?

A: Yes, official labeling lists groups that should exercise caution. These include patients with severe kidney or liver impairment, and the label prohibits use in those whose primary substance of abuse is an opioid or who are currently receiving opioid replacement therapy.

How should Reset be stored and disposed of?

The official storage and disposal profile for this medicine is based on regulatory standards for its active ingredient, Acetaminophen, across various dosage forms.

Official Storage and Handling Requirements

Scope Item Labeled Regulatory Statement
Storage Temperature Store at controlled room temperature, typically 20 C to 25 C.
Environmental Protection Keep in the original container, tightly closed, and away from excessive heat and moisture (e.g., the bathroom). Infusion solutions require protection from light and must not be refrigerated or frozen.
In-Use Stability Once a container for intravenous use is opened, the product must be used within 6 hours; the unused portion must be discarded.
Child-Protection The medicine must be stored out of the sight and reach of children and safety caps should always be locked.

Official Disposal Rules

Official disposal instructions prioritize using a drug take-back location or a prepaid drug mail-back envelope. If those options are unavailable, the medicine must be mixed with an undesirable substance (like coffee grounds or dirt), placed in a sealed container, and thrown into the trash. The product must not be flushed down the toilet.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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