What side effects are associated with this type of intervention?

Common treatments for substance abuse, particularly behavioral interventions like Cognitive Behavioral Therapy (CBT) and web-based programs, generally have minimal physical side effects. However, patients may experience psychological discomfort such as increased anxiety, stress, or emotional distress as they confront and work through their substance use issues. Additionally, there may be challenges related to engagement and adherence, such as high dropout rates and difficulties in maintaining consistent participation.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of substance abuse, particularly opioid use disorder. These include methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are opioid agonists that help reduce withdrawal symptoms and cravings, while naltrexone is an opioid antagonist that blocks the effects of opioids. These medications are often used alongside behavioral interventions such as cognitive-behavioral therapy (CBT) and contingency management to enhance treatment outcomes. The integration of these pharmacological treatments with behavioral therapies is a common approach in managing substance use disorders.

What other types of research exist?

Promising novel alternatives to tailored web-based drug abuse prevention programs for substance abuse patients include: 1) Web-based videoconferencing for substance abuse counseling, which improves access by allowing patients to receive counseling services at home. 2) Behavioral treatments combined with buprenorphine for opioid use disorder, which have shown improved retention and abstinence rates. 3) Computer-assisted therapies like the Therapeutic Education System (TES), which enhance the consistency and efficiency of treatment. 4) Interactive or individually tailored web interventions for smoking cessation, which have been effective in increasing abstinence rates.

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Behavioral Intervention

Free2b for Addiction

N/A

Waitlist Available

Led By Traci M. Schwinn, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-year follow-up

Summary

This trial tests an online program aimed at preventing drug use among teenagers who identify as sexual minorities. The program offers engaging sessions with useful information and support to help these youths avoid drugs.

Who is the study for?

This trial is for teenagers aged 15-17 in the U.S. who identify as gay, lesbian, bisexual, or unsure of their sexual orientation and can speak and read English. They must have private access to a desktop, laptop, or tablet with internet.

What is being tested?

The study is testing 'Free2b', a web-based drug abuse prevention program tailored for young sexual minority individuals against an attention-placebo control to see its effectiveness over time.

What are the potential side effects?

Since this intervention involves educational content rather than medication, traditional side effects are not expected; however, participants may experience emotional discomfort discussing sensitive topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-year follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-year follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of times youth binge drank in the past month

Number of times youth drank alcohol in the past month

Number of times youth smoked cigarettes in the past month

+3 more

Secondary study objectives

Mean scores for Assertiveness

Mean scores for Consequences of Substance Use

Mean scores for Coping

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

9 sessions and website with entertainment features and resources

Group II: ControlPlacebo Group1 Intervention

website with entertainment features and resources

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Free2b

2020

N/A

~1220

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral interventions, such as Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and Contingency Management (CM), are designed to modify the patient's behavior and thought patterns related to substance use. CBT helps patients recognize and change maladaptive thoughts and behaviors, MI enhances intrinsic motivation to change by resolving ambivalence, and CM uses positive reinforcement to encourage abstinence. These mechanisms are crucial for substance abuse patients as they address the psychological and behavioral aspects of addiction, promoting long-term recovery and reducing the likelihood of relapse.

A Process Evaluation of a Substance Use Brief Intervention for Adolescents in a Psychiatric Inpatient Program.Web-based interventions for substance use disorders: a qualitative review.