Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The investigators hypothesize that the combination of an agent that increased baseline dopamine signaling (amphetamine) with one that reduced cocaine-induced dopamine release (topiramate) will improve dopamine regulation and be associated with improved cocaine use outcomes. 99 subjects at each of the two sites whom meet criteria for cocaine dependence, and all other study inclusion and exclusion criteria will be assigned to the 14-week double-blind, placebo-controlled treatment trial. Subjects will be randomized to receive either placebo or MAS-ER and topiramate. This proposal will test the hypothesis that MAS-ER and topiramate will promote cocaine abstinence. Participants who are randomized to the combination medication arm will have their dose titrated to 60 mg MAS-ER daily (over 2 weeks) and 200 mg topiramate a day (over 6 weeks) and maintained on this dose through week 13 of the trial. During week 14, participants will be tapered off both medications. All participants will receive a supportive behavioral treatment that emphasizes study procedure adherence. Starting in week one, all patients will receive incentives for compliance with study procedures on an escalating reinforcement schedule similar to that developed previously and not contingent on urine results. The purpose of the lead-out is to blind patients to the exact point of medication discontinuation and to provide naturalistic data on the effects of medication discontinuation. Moreover, a 3 month follow-up will be conducted to determine what happens to cocaine use after treatment discontinuation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01811940
Study type	Interventional
Source	New York State Psychiatric Institute
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	July 2013
Completion date	June 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04994821` - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study	Phase 2
Completed	`NCT01402492` - Cocaine Use Reduction With Buprenorphine	Phase 2/Phase 3
Completed	`NCT01601743` - Exercise as a Behavioral Treatment for Cocaine Dependence	N/A
Completed	`NCT01176591` - HBPL Study of the Impact of the NK1 Antagonist Aprepitant	Phase 2
Completed	`NCT00880997` - The Efficacy of Doxazosin for Cocaine Users	Phase 1
Completed	`NCT00566969` - Cocaine Withdrawal and Pharmacotherapy Response	N/A
Completed	`NCT00585520` - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues	Phase 1
Completed	`NCT00368290` - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior	Phase 2
Completed	`NCT00385801` - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence	Phase 2
Completed	`NCT00322309` - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects	Phase 2
Completed	`NCT00167245` - Topiramate for Alcohol and Cocaine Dependence	Phase 2
Completed	`NCT00842517` - Long Term Maintenance of Drug Abstinence	Phase 1
Not yet recruiting	`NCT05974202` - rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder	Phase 2
Completed	`NCT04411914` - Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid	Phase 1
Active, not recruiting	`NCT03266939` - Rebalancing the Serotonergic System in Cocaine Dependence	Phase 1
Completed	`NCT02563769` - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study	Phase 1
Recruiting	`NCT06159387` - Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts	Phase 4
Terminated	`NCT02935101` - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants	Phase 2
Completed	`NCT02018263` - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans	Phase 1
Completed	`NCT01573273` - Oxytocin in Cocaine Dependence	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence — TACT2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms