CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Armodafinil +2 moredrug
Likely dose
Armodafinil 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01011218
NCT01011218Phase 2Completed
CompareCT.gov

Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Stanford University·interventional·Posted Nov 11, 2009·Updated Nov 29, 2018

In Brief

A Phase 2 clinical trial evaluating BBT-I, Control, and 1 other intervention for Insomnia and Fatigue. Completed, enrolled 70 participants across 1 site.

Detailed Summary

To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). Participants will be randomized into 4 groups: * Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day. * Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day. * Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention. * Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Fatigue
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2009
Enrollment StartJan 1, 2011
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 16.6 years ago

Interventions

BBT-Ibehavioral

Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone

Controlbehavioral

Control behavioral intervention is a sleep hygiene handout completed by participant.

Armodafinildrug

150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.