InTEGRA vs. MET/CBT for Youth with Alcoholism and Drug Use Disorder

(InTEGRA Trial)

Recruiting at 1 trial location

Overseen By Jenny B O'Connor, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Suicidal ideation, Schizophrenia, Health condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

294 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two therapies for teenagers and young adults with substance use disorder, which involves alcohol or drug issues. One treatment, InTEGRA, combines traditional therapy with 12-step support meetings, while the other, MET/CBT, uses a well-known therapy method. Researchers aim to determine if adding 12-step meetings improves recovery. Participants should be 14-21 years old, have used alcohol or drugs in the past 90 days, and live in Massachusetts or Connecticut. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance recovery options for young people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are attending another substance use disorder treatment program or receiving psychotherapy that could conflict with the study treatments, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the treatments in this trial, InTEGRA and MET/CBT, are safe for participants. Research on similar therapies, such as Integrated Family and Cognitive-Behavioral Therapy (IFCBT) for teenagers, reported no harmful effects. This suggests that InTEGRA, which combines 12-Step Facilitation with MET/CBT, is generally well-tolerated.

Regarding MET/CBT alone, many studies over the years have found it to be an effective and safe treatment for substance use problems. It has been used successfully in various settings and has consistently shown positive results without major safety concerns. Overall, both InTEGRA and MET/CBT have strong safety records, making them promising options for treating substance use issues in teenagers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because InTEGRA combines traditional elements of Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT) with a unique integration of Twelve-Step Facilitation (TSF). This hybrid approach includes guest speakers from 12-step fellowships like Alcoholics Anonymous and Narcotics Anonymous, providing firsthand insights and addressing common myths. Unlike standard MET/CBT, InTEGRA actively involves parents in encouraging their child's participation in 12-step meetings, potentially enhancing long-term recovery outcomes.

What evidence suggests that this trial's treatments could be effective for substance use disorder?

This trial will compare the Integrated Treatment for Enhancing Growth in Recovery (InTEGRA) with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT) for youth with alcoholism and drug use disorder. Studies have shown that InTEGRA can increase participation in 12-step programs, extend sobriety, and reduce substance-related problems. This approach combines 12-Step Facilitation (TSF) with MET/CBT. Research suggests that using these methods together can be effective for individuals with substance use disorders, especially when supported by family and friends.

Cognitive Behavioral Therapy (CBT), a component of MET/CBT, has been proven to reduce substance use. Studies show that CBT is more effective than minimal or general treatments for substance use disorders. Both InTEGRA and MET/CBT support recovery, but InTEGRA's additional focus on 12-step program involvement may offer extra benefits. ^{1 2 6 7 8}

Who Is on the Research Team?

John F Kelly, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adolescents aged 14-21 with substance use disorder, specifically alcohol and cannabis use issues. They must be able to attend sessions in Boston, MA or Farmington, CT. Details on who can't join are not provided.

Inclusion Criteria

DSM 5 alcohol and other drug (AOD) use disorder to maximize generalizability to youth with broad range of AOD involvement

Residence within 60-minute drive from the Boston MGH/Harvard and Farmington UConn treatment sites

Have used AOD in the past 90 days (or in the 90 days prior to being in a controlled environment)

Exclusion Criteria

Lifetime diagnosis of schizophrenia

Suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or others, or a history of self-injurious behavior occurring in past 30 days

Youth attending another AOD treatment program or receiving psychotherapy that could conflict with study treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phone screening followed by in-person intake

Treatment

Participants receive 10 weekly treatment sessions, either InTEGRA or MET/CBT, with a mix of individual and group sessions

10 weeks

10 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups every 3 months for one year

12 months

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• InTEGRA
• MET/CBT

Trial Overview The study compares two treatments for young people with drug problems: InTEGRA combined with MET/CBT versus just MET/CBT. The goal is to see if InTEGRA leads to more involvement in recovery programs, higher sobriety rates, and fewer negative consequences from substance use.

How Is the Trial Designed?

Group I: InTEGRA Experimental Treatment 1 Intervention

10 weekly, in-person or virtual treatment sessions (2 individually-delivered and 8 group sessions). InTEGRA contains many primary treatment elements of MET/CBT, but comparatively less time is spent on these elements to allow for the integration of the TSF content (about 50%). As part of this TSF, for example speakers from 12-step fellowships such as Marijuana Anonymous (MA), Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) are invited to share their experiences and discuss myths and facts related to attendance at 12-step meetings as well as answer any questions participants have about these fellowships. During an orientation session, parents of youth in the InTEGRA condition only (not MET/CBT alone) are given information about the potential benefits of 12-step meeting participation and a list of Young Person's 12-step meetings and encouraged to facilitate their child's participation during and after treatment.

Group II: MET/CBT Active Control 1 Intervention

10 weekly, in-person or virtual treatment sessions (2 individually-delivered and 8 group sessions) modified from MET/CBT approaches (Webb, Scudder, Kaminer, \& Kadden, 2002; Sampl \& Kadden 2001) tested in the Cannabis Youth Treatment Study (Dennis et al. 2004).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Integrated Family and Cognitive-Behavioral Therapy (IFCBT) significantly reduced substance use in adolescents compared to the Drugs Harm Psychoeducation curriculum (DHPE), with IFCBT participants using alcohol an average of 2.03 days per month versus 6.06 days for DHPE participants, and marijuana 5.67 days versus 13.83 days, respectively.

IFCBT not only decreased substance use but also improved psychosocial skills in youth and adaptive communication and involvement in parents, indicating its effectiveness in addressing both individual and family dynamics in treating adolescent drug abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated family and cognitive-behavioral therapy for adolescent substance abusers: a stage I efficacy study. Latimer, WW., Winters, KC., D'Zurilla, T., et al.[2019]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/435168?per_page=100&only_recruiting=0&only_eligible=0

Integrated Treatment for Enhancing Growth in Recovery ... The treatment conditions are InTEGRA, which integrates key elements of TSF with MET/CBT, and MET/CBT alone.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3974008/

The effectiveness of integrated treatment in patients with ... Integrated Treatment (IT) has proved effective in treating patients with Substance Use Disorders (SUD) co-occurring with severe Mental Disorders (MD), ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06395467

Integrated Treatment for Enhancing Growth in Recovery ... It is hypothesized that higher network support for AOD use, abstinence motivation, and greater AOD severity, will have a better response to InTEGRA. Explore ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06395467/integrated-treatment-for-enhancing-growth-in-recovery-during-adolescence

Integrated Treatment for Enhancing Growth in Recovery ... It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment, higher abstinence ...

5. withpower.com withpower.com/trial/phase-alcohol-use-disorders-aud-5-2024-e52b7

InTEGRA vs. MET/CBT for Youth with Alcoholism and Drug ... It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment, higher abstinence rates, and fewer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11149235/

A data-driven approach to implementing the HPTN 094 ... We used a hybrid, type I, embedded, mixed method, data-driven approach to identify and characterize viable implementation neighborhoods for the HPTN 094 ...

7. hptn.org hptn.org/sites/default/files/inline-files/HPTN%20094%20Protocol%20Final%20Version%201.0%2015%20July%202020.pdf

HPTN 094 INTEGRA: A Vanguard Study of Health Service ... I will conduct the study in accordance with the provisions of this protocol and all applicable protocol- related documents.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11003516/

Adolescent Substance Use Disorders Adolescent substance use is associated with the leading causes of death in this age group: unintentional injury, suicide, and violence.