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Prescription Drug AbuseNCT03219190

A High School Program for Preventing Prescription Drug Misuse

A study testing LST High School Hybrid in people with Prescription Drug Abuse and Substance Abuse, run by National Health Promotion Associates, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project will develop and evaluate a program to prevent prescription drug misuse in high school students Read more about this study

Who is it for?
Ages 14 to 18 yearsHealthy volunteers can take part
What is being tested?
LST High School Hybrid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,804 participants
Where
1 siteUnited States
Study dates
1 Feb 2022to 1 Jul 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • High school aged-youth

Who cannot join

  • All students in the classroom were eligible to participate in the intervention. However, at the discretion of local school staff, students with significant cognitive impairment or severe learning disabilities were excused from completing the study questionnaire.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Health Promotion Associates, Inc.

    White Plains, New York, 10604

Other trials in United States

About this study

This project will develop and evaluate a program to prevent prescription drug misuse in high school students

Read the detailed description

This Fast-Track SBIR project is designed to address the critical need for an effective primary prevention approach for prescription misuse (PDM), an urgent public health crisis in the United States. The project involves developing and testing an innovative new approach to the primary prevention of PDM among high school students utilizing e-learning and small group facilitator-led intervention modalities. The intervention is an adaptation of the evidence-based substance abuse prevention approach called Life Skills Training (LST). The adapted intervention will address the relationship between PDM and alcohol, tobacco and other drug (ATOD) use and abuse; positively change social norms surrounding ATOD and PDM; discourage diversion of prescription medications; enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios.

Administrative Correction: This record was updated post-study to rectify administrative errors in the original registration and to reflect operational changes necessitated by the COVID-19 pandemic.

Correction of Secondary Outcomes: The Secondary Outcomes section has been corrected to include variables that were specified in several sections of the original registration and collected during the trial, but were inadvertently omitted from the "Outcome Measures" field in the initial registration. These include: alcohol use, tobacco use, marijuana use, inhalant use, perceived risk of prescription sedative, painkiller, and stimulant misuse, and life skills (self-regulation, communication, media resistance, anxiety management, refusal skills).

Update on Study Duration and Follow-up: The COVID-19 pandemic caused significant delays in study implementation and data collection. Although the original protocol specified 12- and 24-month follow-ups, the 24-month assessment was canceled because the study delays extended the timeline beyond the NIH/NIDA performance period. Additionally, widespread school closures and access restrictions resulted in high attrition at the 12-month time point, rendering those data insufficient for meaningful analysis. Consequently, the study analysis focuses exclusively on the immediate post-intervention timeframe.

Clarification on Terminology: Although our original grant application and ClinicalTrials.gov registration used the term Prescription Drug Abuse (PDA), we have adopted the more contemporary term Prescription Drug Misuse (PDM) to align with current best practices. PDM is defined here as the use of prescription drugs without a doctor's prescription.

Being tested
LST High School Hybrid
Keywords
Adolescence, Prescription Drug Misuse, Prevention, Hybrid, E-learning, Cigarette Smoking, Alcohol Use, Life Skills
Medical subject headings
Substance-Related Disorders, Prescription Drug Misuse, Cigarette Smoking, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LST High School HybridBehavioural

    The preventive intervention for high school PDM will: (1) utilize both online e-learning modules and interactive classroom sessions to address PDM and concurrent alcohol/drug abuse; (2) positively change social norms surrounding PDM and alcohol/drug abuse; (3) change positive expectancies about the benefits of PDM; (4) discourage diversion of prescription medication; (5) enhance protective factors by building social, self-regulation, and relationship skills through interactive learning and behavioral rehearsal scenarios; and (6) include online booster sessions.

Study groups in NCT03219190
Study groupRoleWhat they receive
LST High School HybridExperimentalProvided with the prevention program, consisting of e-learning modules and classroom sessions.
Receives: Behavioral: LST High School Hybrid
Treatment as Usual (Control)No interventionStandard health education normally provided by the school

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prescription Drug Misuse (i.e., Prescription Drug Use Without a Doctor's Prescription)

    This measure includes prescription drug misuse of sedatives, painkillers, and stimulants.

    Frequency of sedative, painkiller, and stimulant use without a doctor's prescription; measured on a 9-point scale, including Never (1), A few times but NOT in the past year (2), A few times a year (3), Once a month (4), A few times a month (5), Once a week (6), A few times a week (7), Once a day (8), More than once a day (9);

    Unabbreviated scale title: Prescription Drug Misuse (i.e., prescription drug use without a doctor's prescription); Minimum value = 1; maximum value = 9; Higher scores are a worse outcome

    Measured: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

Secondary outcomes (7)

  1. Alcohol Use

    This measure includes alcohol use and alcohol intoxication. Frequency of alcohol use and alcohol intoxication; measured on a 9-point scale, including Never (1), A few times but NOT in the past year (2), A few times a year (3), Once a month (4), A few times a month (5), Once a week (6), A few times a week (7), Once a day (8), More than once a day (9);

    Unabbreviated scale title: Alcohol Use; Minimum value = 1; maximum value = 9; Higher scores are a worse outcome

    Measured: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  2. Tobacco Use

    This measure includes tobacco use. Frequency of cigarette/tobacco use; measured on a 9-point scale, including Never (1), A few times but NOT in the past year (2), A few times a year (3), Once a month (4), A few times a month (5), Once a week (6), A few times a week (7), Once a day (8), More than once a day (9);

    Unabbreviated scale title: Tobacco Use; Minimum value = 1; maximum value = 9; Higher scores are a worse outcome

    Measured: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  3. Marijuana Use

    This measure includes marijuana use. Frequency of marijuana use; measured on a 9-point scale, including Never (1), A few times but NOT in the past year (2), A few times a year (3), Once a month (4), A few times a month (5), Once a week (6), A few times a week (7), Once a day (8), More than once a day (9);

    Unabbreviated scale title: Marijuana Use; Minimum value = 1; maximum value = 9; Higher scores are a worse outcome

    Measured: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  4. Inhalant Use

    This measure includes inhalant use; measured on a 9-point scale, including Never (1), A few times but NOT in the past year (2), A few times a year (3), Once a month (4), A few times a month (5), Once a week (6), A few times a week (7), Once a day (8), More than once a day (9);

    Unabbreviated scale title: Inhalant Use; Minimum value = 1; maximum value = 9; Higher scores are a worse outcome

    Measured: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  5. Substance Use Intentions

    This measure includes intentions to use substances: Intentions to use alcohol, get drunk, use tobacco, marijuana, and inhalants within the next year; measured on a 5-point scale from "Definitely Not" to "Definitely Will";

    Unabbreviated scale title: Substance Use Intentions; Minimum value = 1; maximum value = 5; Higher scores are a worse outcome

    Measured: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  6. Perceived Risk of Prescription Drug Misuse

    This measure includes perceived risk of harm associated with using prescription sedatives, painkillers, and stimulants when prescribed for someone else, measured on a 4-point scale from "No Risk" to "Great Risk;" also option for "Can't say, drug unfamiliar";

    Unabbreviated scale title: Perceived Risk of Prescription Drug Misuse; Minimum value = 1; maximum value = 4; Higher scores are a better outcome

    Measured: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  7. Life Skills

    Self-regulation skills: the ability to control one's thoughts, feelings, and behaviors; Communication skills: the ability to communicate effectively; Media resistance skills: the ability to resist messages from the media; Anxiety management skills: the ability to recognize and manage physical manifestations of anxiety; Refusal skills: the ability to resist pressure to use substances; All response options on a 5-point scale from "Strongly Disagree" to "Strongly Agree; except Communication skills, with response options on a 5-point scale from "Never" to "Always";

    Unabbreviated scale title: Life Skills; Minimum value = 1; maximum value = 5; Higher scores are a better outcome

    Measured: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2017
  2. Study start1 Feb 2022
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,804 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03219190
Sponsor's protocol ID
1R44DA04327301
Status last verified
Feb 2026
First submitted
13 Jul 2017
Last updated
10 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Retraction of "Preventing tobacco and alcohol use among high school students through a hybrid online and in-class intervention: A randomized controlled trial," by Williams et al. (2025). Psychol Addict Behav. 2026 Feb;40(1):125. doi: 10.1037/adb0001131.

    PubMed 41627337

Questions about this trial

What is this clinical trial studying?

A study testing LST High School Hybrid in people with Prescription Drug Abuse and Substance Abuse, run by National Health Promotion Associates, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prescription Drug Misuse (i.e., Prescription Drug Use Without a Doctor's Prescription) (time frame: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03219190, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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