NCT01811940 (TACT2) is a Phase 2/Phase 3 clinical trial of Adderall-ER in Cocaine Dependence, sponsored by New York State Psychiatric Institute.

Who is sponsoring NCT01811940?

NCT01811940 is sponsored by New York State Psychiatric Institute.

What drugs are being tested in NCT01811940?

Interventions in NCT01811940: Adderall-ER, Topiramate, Placebo.

What condition does NCT01811940 study?

NCT01811940 studies Cocaine Dependence.

Is NCT01811940 still recruiting?

NCT01811940 is currently completed. Last updated 22 April 2019.

Are results published for NCT01811940?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-22 · How we verify

NCT01811940: TACT2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

Completed Phase 2/Phase 3 Results posted Last updated 22 April 2019

What this trial tests

Phase 2/Phase 3 trial testing Adderall-ER in Cocaine Dependence in 169 participants. Completed in 1 June 2017.

Timeline

1 July 2013

Primary endpoint
1 June 2017

1 June 2017

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	169
Start date	1 July 2013
Primary completion	1 June 2017
Estimated completion	1 June 2017
Sites	2 locations across United States

Drugs / interventions tested

Adderall-ER
Topiramate (topiramate) — full drug profile →
Placebo

Conditions studied

Cocaine Dependence — all drugs for Cocaine Dependence →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 60, any sex, with Cocaine Dependence. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Three Weeks of Cocaine Abstinence at End of Study
Time frame: assessed during 14 weeks of trial, presented for last 3 weeks
The number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week.

Sponsor's own description

The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Extended release mixed amphetamine salts and topiramate for cocaine dependence: A randomized clinical replication trial with frequent users.
Levin FR, Mariani JJ, Pavlicova M, Choi CJ, et al · · 2020 · cited 34× · PMID 31753736 · DOI 10.1016/j.drugalcdep.2019.107700
Anticonvulsants for cocaine dependence.
Minozzi S, Cinquini M, Amato L, Davoli M, et al · · 2015 · cited 22× · PMID 25882271 · DOI 10.1002/14651858.cd006754.pub4

Verify or expand the search:

Other recruiting trials for Cocaine Dependence

Currently open trials in the same condition.

NCT06189690 — Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder · NA · recruiting

Other New York State Psychiatric Institute trials

Trials by the same sponsor.

NCT05416658 — Shared Decision Making for Antipsychotic Medications · NA · not yet recruiting
NCT07423546 — A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia · Phase 1, PHASE2 · not yet recruiting
NCT05339256 — Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual · Phase 2 · not yet recruiting
NCT05563948 — Repeated Administration of Cannabis Varying in THC and CBD · Phase 2 · suspended
NCT06977308 — A Multimodal Imaging Study of Dopamine in Early Psychosis · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01811940 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by New York State Psychiatric Institute
Last refreshed: 22 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01811940.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing