Treatment Outcomes Among Patients With Prescription Narcotic Drug Use Disorder

Drug Use Disorders Clinical Trial

— TAPE  

Official title:

Characteristics of and Treatment Outcomes Among Patients With Prescription Narcotic Drug Use Disorder: a Naturalistic Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03713983
• Other study ID #: TAPE 2018
• Status: Active, not recruiting
• Start date: October 23, 2018
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Background: The study covers prescription narcotics and focuses on opioids and benzodiazepines (and related compounds). The use of opioids and benzodiazepines is relatively safe in the short term. However, long-term use for anxiety and chronic non cancer pain has limited scientific support. Moreover, use of opioids and benzodiazepines has been associated with a variety of adverse effects and both opioids and benzodiazepines are highly addictive.

Clinical guidelines advise that narcotic analgesics and sedatives should not be used as first-choice treatments for pain, anxiety, or insomnia. Instead, guidelines recommend psychotherapy, physiotherapy, and non-narcotic pharmacological drugs (such as non-steroidal anti-inflammatory drugs and antidepressants), alternatives that are less addictive and more beneficial over time. Despite such recommendations, benzodiazepines and opioids are commonly prescribed and used over the long term.

For patients who seek treatment for narcotic drug use disorder, tapering by gradual dose reduction is an important component but its effect is not well studied.

Aims: This study aims to investigate the clinical trajectory and treatment outcome among patients with narcotic drug use disorder at specialized addiction treatment services.

Specific aims:

1) The outcome of tapering of narcotic drugs at 6, 12, and 24 months follow-up 2) How the treatments provided (e.g., tapering; tapering plus psychological treatment) are associated with patient outcomes 3) How psychiatric symptoms and comorbidity are associated with patient outcomes 4) Predictors of narcotic drug abstinence and retention in treatment 5) The validity of psychiatric diagnoses in relation to drug use (i.e., whether the diagnosis changes significantly following drug detoxification)

Methods: This is a naturalistic, prospective study of outcomes following treatment at a specialized service for prescription narcotic drug use disorder. Standardized screening and assessment tools will be used to investigate patients at baseline, evaluate the treatment patients receive over a 24-month period, and evaluate patient outcomes.

All patients starting a new treatment period at the center will be invited to participate at the first visit to the clinic or as soon as possible thereafter. Written informed consent will be obtained. The study will conform to Good Clinical Practice (ICH-GCP) and the principles outlined in the Declaration of Helsinki.

Measurements in the study include: urine drug screening, blood chemistry including screening for alcohol biomarkers, Drug Use Disorders Identification Test, Alcohol Use Disorders Identification Test, Patient Health Questionnaire, EuroQol -5D, Clinical Global Impressions Scale, Adult ADHD Self-Rating Scale - Screening, The Mini International Neuropsychiatric Interview, Version 7, the Life Events Checklist, the Insomnia Severity Index, the Benzodiazepine Withdrawal Symptom Questionnaire, the Subjective Opioid Withdrawal Scale, Generalized Anxiety Disorder - 7, Numeric Rating Scale for Pain, PROMIS Pain Interference - Short Form 4a, patient satisfaction, Substance use questionnaire, and Structural Clinical Interview for DSM-IV Axis II Personality Disorders Screening.

Information regarding treatment at the unit (e.g. number and type of visits, somatic or psychiatric diagnoses) will be collected from medical records using the ICD codes. Diagnostic assessment will be performed according to both ICD-10 and DSM-5.

The protocol allows for a 10-year follow-up using national registries.

Study procedures and data collection will be regularly monitored by an external quality assurance organization.

Analyses will be conducted using statistical software; p values < 0.05 will be considered significant. Prescription drug use, retention in treatment and the percentage of participants with negative urine samples and self-reported abstinence will be calculated at follow-ups. Regression analyses will be computed to assess factors associated with the outcome of tapering.

To find a 95 % confidence interval around the point estimate (drug abstinence) with a margin of error not exceeding +/- 5 percentage points, where the assumed proportion is 0.3, at least 322 patients must be included. Alternatively, to find a 95 % confidence interval with a margin of error not exceeding +/- 10 percentage points, at least 81 patients must be included. A minimum of 81 patients will be included in the study. The study will include an analysis of dropout.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Inability to understand spoken and written study information.

• Having started tapering prior to the start of the study.

Related Conditions & MeSH terms

• Drug Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Observational study
Observational study

Locations

Country	Name	City	State
Sweden	Stockholm Centre for Dependency Disorders (www.beroendecentrum.se)	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Johan Franck	Public Health Agency of Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnoses of substance use disorder(s)	Number of participants with diagnoses of substance use disorder according to ICD-10	6-, 12-, and 24-month follow-up
Other	Self-reported substance use	self-reported data using standard question in ASI	6-, 12-, and 24 month follow-up
Other	Psychiatric comorbidity	Number of participants with psychiatric diagnoses according to ICD-10	6-, 12-, and 24-month follow-up
Other	Personality traits	SCID-2 Structured Clinical Interview for DSM-IV-Axis 2 Disorders, screening	6-, 12-, and 24-month follow-ups
Other	Insomnia	Insomnia Severity Index (ISI)	6-, 12-, and 24-month follow-up
Other	Pain Scale	The PROMIS pain interference - Short form 4a (PROMIS-PI SF 4a), is a four-item questionnaire measuring the extent pain interferes with functioning in daily life. Items are rated on a five-point scale ranging from "not at all" to "very much". Summed scores range from 4-20, higher scores indicating greater pain interference. The scale is recommended by the National Institute of Drug Abuse (NIDA).	6-, 12-, and 24-month follow-up
Other	Quality of life, including self-rated health	Measured by EuroQol 5D (EQ-5D), a two-part health index. Part one covers self-rated problems in five domains: mobility, self-care, everyday activities, pain/discomfort, and anxiety/depression. Each domain is rated on a five-level scale that indicates no problems to extreme problems. Part two consist of a visual analog scale (EQ-5D VAS); respondents assess their subjective health status on a 0 to 100 scale, where 0 is "the worst health you can image" and 100 "the best health you can imagine."	6-, 12-, and 24-month follow-up
Other	Somatic health	Number of participants with somatic diagnoses according to ICD-10	6-, 12-, and 24-month follow-up
Other	Withdrawal symptoms Opioids	Measured by the Subjective Opiate Withdrawal Scale (SOWS). The scale measures 16 common symptoms of opiate withdrawal. Symptoms are rated on a scale between 0 and 4, from "not at all" to "extremely." Higher scores indicating more withdrawal symptoms.	6-, 12-, and 24-month follow-up
Other	Substitution treatment with opioids	Prescription registry data	6-, 12-, and 24-month follow-up
Other	Withdrawal symptoms Benzodiazepines	The Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)	6-, 12-, and 24-month follow-up
Other	Self-reported patient satisfaction with treatment	Self-report data using standard question in the National Patient Survey (Sweden). Items measures patients' experience and satisfaction with care. Items are rated on a scale between 1 ("Not at all") and 5 ("Totally agree"), with the possibility to answer "Not applicable".	6-, 12-, and 24-month follow-up
Primary	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	Prescription narcotic drug abstinence	Measured by drug testing and self-reported substance use	6-, 12- and 24-month follow-up or at last visit
Secondary	Retention in treatment	Data collected from scheduled visit	6-, 12- and 24-month follow-up or at last visit

External Links

•   co-PI home page
•   PI home page