CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 145 enrolled
Drug / intervention
Mixed-Amphetamine Salts- Extended Release (MAS-ER) +2 moredrug
Likely dose
Mixed-Amphetamine Salts- Extended Release (MAS-ER) 80 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/NCT01986075
NCT01986075Phase 2Completed
CompareCT.gov

A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

New York State Psychiatric Institute·interventional·Posted Nov 18, 2013·Updated Jan 25, 2022

In Brief

A Phase 2 clinical trial evaluating Computer-assisted behavior therapy, Mixed-Amphetamine Salts- Extended Release (MAS-ER), and 1 other intervention for Cocaine Dependence. Completed, enrolled 145 participants across 1 site.

Detailed Summary

This study will investigate a treatment strategy in which a computer-assisted behavioral intervention will be used to help individuals stop their use of cocaine. A medication will be combined with the behavioral treatment among those individuals who do not respond to the behavioral intervention alone. The primary hypothesis of the study is that among cocaine dependent individuals who fail to respond to an initial trial of behavioral therapy, a greater proportion of individuals will benefit from the combined treatment (behavior therapy plus medication) compared to individuals in the comparison group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 18, 2013
Enrollment StartJan 1, 2014
Primary CompletionJan 1, 2021
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 12.6 years ago

Interventions

Computer-assisted behavior therapybehavioral

TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.

Mixed-Amphetamine Salts- Extended Release (MAS-ER)drug

80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT

Placebodrug

Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)