Treatment Outcomes Among Patients With Prescription Narcotic Drug Use Disorder

NCT03713983 | Active Not Recruiting DMC

• 1 other identifier: TAPE 2018
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study follows up patients who receive standard treatment for prescription narcotic drug use disorder, including opioids, benzodiazepines, and benzodiazepine-like drugs (z-drugs), at a specialized addiction service. The overall goal is to evaluate the proportion of patients who reduce or cease using prescription narcotics and the factors associated with treatment outcomes. No new treatments will be tested. Instead, the results will be used as the basis for a future randomized controlled trial to optimize treatment for narcotic drug use disorder.

Conditions

Drug Use Disorders

Keywords

behavior, addictive; addiction medicine; substance-related disorders; abuse, narcotic; addiction, narcotic; analgesics, narcotic; opioid-related disorders; benzodiazepines; prescription drugs

Outcome Measures

Primary Outcomes (1)

• Change in prescription narcotic drug use

  Change in dosage of prescription narcotic drugs

  6-, 12- and 24-month follow-up or at last visit; 10-year follow-up.

Secondary Outcomes (2)

• Prescription narcotic drug abstinence

  6-, 12- and 24-month follow-up or at last visit

• Retention in treatment

  6-, 12- and 24-month follow-up or at last visit

Other Outcomes (12)

• Diagnoses of substance use disorder(s)

  6-, 12-, and 24-month follow-up

• Self-reported substance use

  6-, 12-, and 24 month follow-up

• Psychiatric comorbidity

  6-, 12-, and 24-month follow-up

Interventions

Observational study OTHER

Observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients starting a new treatment period for prescription narcotic drug use disorder

You may qualify if:

• Patients seeking treatment for prescription narcotic drug use disorder (ICD-10: F111, F112, F131, and F132)
• ≥ 18 years
• Willing to participate and who have provided written informed consent.

You may not qualify if:

• Inability to understand spoken and written study information.
• Having started tapering prior to the start of the study.

Sponsors & Collaborators

• Johan Franck: lead
• Public Health Agency of Sweden: collaborator

Study Sites (1)

Stockholm Centre for Dependency Disorders (www.beroendecentrum.se)

Stockholm, Sweden

Location

Related Publications (1)

• Burmester S, Kruger C, Hallgren J, Westman J, Franck J. A prospective cohort of treatment-seeking patients with problematic use of prescription narcotic drugs: study protocol and baseline characteristics. BMC Psychiatry. 2024 Dec 20;24(1):937. doi: 10.1186/s12888-024-06368-w.

  PMID: 39707239 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive; Narcotic-Related Disorders; Opioid-Related Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Johan Franck, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 22, 2018
• Study Start: October 23, 2018
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

SE (1)