NCT02831894

The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation

Completed Phase 2 Last updated 30 October 2019

What this trial tests

Phase 2 trial testing 0% Hypnotic Medication Taper in Hypnotic Dependence Among Those With Insomnia in 74 participants. Completed in 30 June 2019.

Timeline

2 November 2015

Primary endpoint
30 June 2018

30 June 2019

Quick facts

Lead sponsor	National Jewish Health
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	74
Start date	2 November 2015
Primary completion	30 June 2018
Estimated completion	30 June 2019
Sites	1 location across United States

Drugs / interventions tested

• 0% Hypnotic Medication Taper — full drug profile →
• 25% Hypnotic Medication Taper — full drug profile →
• 10% Hypnotic Medication Taper — full drug profile →

Conditions studied

• Hypnotic Dependence Among Those With Insomnia — all drugs for Hypnotic Dependence Among Those With Insomnia →

Sponsor

National Jewish Health — full company profile →

Who can join

21 and older, any sex, with Hypnotic Dependence Among Those With Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Treatment seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent remain on these agents for more than five years. Whereas some patients may appreciate partial or full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these agents may not represent optimal therapy. Many insomnia patients who participate in non drug insomnia therapy such as as cognitive behavioral insomnia therapy or Cognitive Behavioral Therapy For Insomnia (CBTI) achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control (CTRL) condition in which their medication was not tapered. After the 20 week tapering period the study blind was eliminated and those in the CTRL condition were offered an open label tapering period. All patients were assessed for hypnotic use at the end of their respective tapering periods and then again 3 months later. Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used. This line of research should inform clinical practice by helping to refine guidelines for tapering controlled substance hypnotic medications.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adherence to behavioral recommendations of cognitive behavioral therapy for insomnia predicts medication use after a structured medication taper.
   Edinger JD, Wamboldt FS, Johnson RL, Simmons B, et al · · 2023 · cited 3× · PMID 37086054 · DOI 10.5664/jcsm.10616