NCT01986075

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 25, 2022

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

7 years

First QC Date

November 11, 2013

Results QC Date

November 24, 2021

Last Update Submit

January 24, 2022

Conditions

Cocaine Dependence

Keywords

Cocaine Dependence TreatmentComputer-assisted therapyPharmacotherapy

Outcome Measures

Primary Outcomes (1)

  • Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial.

    The primary outcome measure will be a binary indicator (yes or no) of at least 3 consecutive weeks of urine toxicology confirmed self-reported abstinence during the last three weeks of the trial.

    weeks 12-14 of trial

Study Arms (2)

Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)

EXPERIMENTAL

Patients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.

Behavioral: Computer-assisted behavior therapyDrug: Mixed-Amphetamine Salts- Extended Release (MAS-ER)

Computer-assisted CBT plus placebo

PLACEBO COMPARATOR

Patients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial. Computer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week.

Behavioral: Computer-assisted behavior therapyDrug: Placebo

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.

Also known as: Therapeutic Educational System (TES)
Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)Computer-assisted CBT plus placebo
Mixed-Amphetamine Salts- Extended Release (MAS-ER)DRUG

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

Also known as: Adderall XR
Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
PlaceboDRUG

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

Also known as: Computer-assisted CBT, TES
Computer-assisted CBT plus placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-V criteria for cocaine use disorder.
  • Used cocaine at least four days in the past month.
  • Age 18-60.
  • Able to give informed consent and comply with study procedures

You may not qualify if:

  • Meets DSM-V criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
  • Participants with MDD, with symptom severity that exceeds a HAM-D score of 20, and/or any other current Axis I psychiatric disorder as defined by DSM-V supported by the MINI that in the investigator's judgment are unstable, would be disrupted by study medication, or are likely to require specialized pharmacotherapy or psychotherapy during the study period.
  • History of seizures, unexplained loss of consciousness, or traumatic brain injury.
  • History of allergic reaction to candidate medication (amphetamine).
  • Significant current suicidal risk.
  • Pregnancy, lactation, or failure in sexually active female patients to use adequate contraceptive methods.
  • Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension, acute hepatitis, uncontrolled diabetes.
  • Elevated transaminase levels (\> 3x the normal limit).
  • Coronary vascular disease
  • History of failure to respond to a previous adequate trial of the candidate medication.
  • Current physiological dependence on any other substance other than nicotine or cannabis that would require a medically supervised detoxification.
  • Currently being prescribed psychotropic medication by another physician.
  • Are legally mandated (e.g. to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

STARS

New York, New York, 10032, United States

Location

Related Publications (3)

  • Bickel WK, Marsch LA, Buchhalter AR, Badger GJ. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol. 2008 Apr;16(2):132-43. doi: 10.1037/1064-1297.16.2.132.

    PMID: 18489017BACKGROUND

  • Carpenter KM, Choi CJ, Basaraba C, Pavlicova M, Brooks DJ, Brezing CA, Bisaga A, Nunes EV, Mariani JJ, Levin FR. Mixed amphetamine salts-extended release (MAS-ER) as a behavioral treatment augmentation strategy for cocaine use disorder: A randomized clinical trial. Exp Clin Psychopharmacol. 2024 Feb;32(1):112-127. doi: 10.1037/pha0000676. Epub 2023 Sep 21.

    PMID: 37732961DERIVED

  • Blevins D, Carpenter KM, Martinez D, Mariani JJ, Levin FR. An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders. Contemp Clin Trials. 2020 Nov;98:106187. doi: 10.1016/j.cct.2020.106187. Epub 2020 Oct 18.

    PMID: 33086160DERIVED

Related Links

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

SLI381TES

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Kenneth Carpenter, PhD
Organization
New York State Psychiatric Institute
kenneth.carpenter@nyspi.columbia.edu
646-774-8181

Study Officials

  • Frances R Levin, M.D.

    Columbia University/New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Following an initial 4 week period where participants received computer-assisted behavioral intervention based on the community reinforcement approach with contingency management (CRA + CM), individuals who failed to achieve abstinence will continue the behavioral treatment (CRA + CM) and will be randomly assigned, in parallel, to a behavioral therapy enhancement strategy that will include either Mixed Amphetamine Salts-Extended Release (80mg) or placebo.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Substance Use Disorder

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 18, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 25, 2022

Results First Posted

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)