Cocaine DependencePhase 1/2NCT01986075

A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

A Phase 1/2 study testing Computer-assisted behavior therapy and Mixed-Amphetamine Salts- Extended Release (MAS-ER) in people with Cocaine Dependence, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Cocaine Dependence
What is being tested?: Computer-assisted behavior therapy and Mixed-Amphetamine Salts- Extended Release (MAS-ER)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 145 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Jan 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Show all 14Show fewer

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.
Body Mass Index (BMI) < 18kg/m2. (amphetamine may produce weigh loss thus a minimum BMI cut-off is being used for study inclusion).

Trial locations and contacts

1 site in 1 country.

United States1 site

STARS
New York, New York, 10032

Other trials in United States

About this study

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.

Read the detailed description

Cocaine Dependence is associated with substantial social, physical, and neurobiological problems. Psychosocial treatments can be helpful for many individuals. However, a significant proportion of individuals do not benefit from counseling alone. Our research group has demonstrated that deficient dopamine transmission, predicts poor response to a behavioral treatment and that a regiment that included an agonist replacement strategy with stimulants maybe effective for promoting abstinence in severe cocaine dependent patients.

In this 15-week study 145 treatment-seeking cocaine dependent participants will receive a computer-assisted behavioral intervention based on the community reinforcement approach with contingency management (CRA + CM). The counseling approach will include both computer-assisted life skills training via and counseling. Individuals who fail to achieve abstinence will continue the behavioral treatment (CRA + CM) and will be randomly assigned to a behavioral therapy enhancement strategy that will include either Mixed Amphetamine Salts-Extended Release (80mg) or placebo.

Conditions: Cocaine Dependence
Being tested: Computer-assisted behavior therapy, Mixed-Amphetamine Salts- Extended Release (MAS-ER), Placebo
Keywords: Cocaine Dependence Treatment, Computer-assisted therapy, Pharmacotherapy
Medical subject headings: Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computer-assisted behavior therapyBehavioural
Also called Therapeutic Educational System (TES)
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
Also called Adderall XR
80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT
PlaceboDrug
Also called Computer-assisted CBT, TES
Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)

Study groups in NCT01986075
Study group	Role	What they receive
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. Receives: Behavioral: Computer-assisted behavior therapy; Drug: 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. Receives: Behavioral: Computer-assisted behavior therapy; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: weeks 12-14 of trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jan 2021

First posted18 Nov 2013 (estimated)
Study startJan 2014
Primary completionJan 2021
Study completionJan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cocaine DependenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01986075
Sponsor's protocol ID: #6850
Other IDs: R01DA034087-01A1
Status last verified: Jan 2022
First submitted: 11 Nov 2013
Last updated: 25 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 18489017
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.
PubMed 37732961
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.
PubMed 33086160

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Active, not recruitingPhase 1
AAV8-hCocH for Cocaine Use Disorder
Cocaine Dependence, in Remission

All Cocaine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
ClinicalTrials.gov ID: NCT01986075
Acronym / sponsor ID: #6850
Conditions: Cocaine Dependence
Keywords: Cocaine Dependence Treatment, Computer-assisted therapy, Pharmacotherapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jan 2014 (actual)
Primary completion: Jan 2021 (actual)
Study completion: Jan 2021 (actual)
First posted: 18 Nov 2013 (estimated)
Results: Posted 25 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)	Experimental	Behavioral: Computer-assisted behavior therapy, Drug: Mixed-Amphetamine Salts- Extended Release (MAS-ER)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.
Computer-assisted CBT plus placebo	Placebo comparator	Behavioral: Computer-assisted behavior therapy, Drug: PlaceboPatients 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computer-assisted behavior therapyAlso: Therapeutic Educational System (TES)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.	Behavioural	Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER), Computer-assisted CBT plus placebo
Mixed-Amphetamine Salts- Extended Release (MAS-ER)Also: Adderall XR80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT	Drug	Computer-assisted CBT plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)
PlaceboAlso: Computer-assisted CBT, TESWill receive computer -assisted CBT and placebo (instead of active Adderall-XR)	Drug	Computer-assisted CBT plus placebo

Primary outcome

Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial.
Time frame: weeks 12-14 of 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.

Results and safety

Results posted to the registry on 25 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)	0	0
Computer-assisted CBT Plus Placebo	0	0
Computer- Assisted CBT With Contingency Management	145	86

Primary outcome: Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial.

Time frame: weeks 12-14 of trial. Count of participants. Unit: Participants

Measure	Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER) n = 45	Computer-assisted CBT Plus Placebo n = 41
Value	7	5

Adverse events

Time frame: During 15 weeks of trial, or length of individual's participation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Computer-assisted CBT Plus Mixed-Amphetamine Salts- Extended Release (MAS-ER)	1 of 45 (2.2%)	26 of 45 (57.8%)	0 of 45
Computer-assisted CBT Plus Placebo	1 of 41 (2.4%)	11 of 41 (26.8%)	0 of 41
Non-randomized CBT Plus CM	4 of 59 (6.8%)	2 of 59 (3.4%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18489017Bickel 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.
Derived from this study: PubMed 37732961Carpenter 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.
Derived from this study: PubMed 33086160Blevins 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.
Click here for more information about the study and clinicLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Cocaine Dependence

Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Active, not recruitingPhase 1
AAV8-hCocH for Cocaine Use Disorder
Cocaine Dependence, in Remission

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frances R Levin, M.D. principal investigator

Columbia University/New York State Psychiatric Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial. (time frame: weeks 12-14 of trial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01986075, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.