Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00553319

Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence — CAMP  

Cocaine Dependence Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence

Clinical Trial Summary

The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.

Clinical Trial Description

Specific Aim 1: To determine the efficacy of ER-MAS in promoting cocaine abstinence and ADHD improvement among comorbid ADHD and cocaine-dependent patients.

Primary Hypothesis: benzoylecgonine positive urine screens will decrease with greatest to least reductions from 80mg>60mg>PBO (placebo).

Hypothesis 2: ADHD-Rating Scale will decrease with greatest to least reductions from 80mg>60mg>PBO.

Specific Aim 2: To determine the effect of ER-MAS on improving general functioning and impulsivity among comorbid ADHD and cocaine-dependent patients.

Hypothesis 4: There will be greater improved CGI (clinical global impression scale) scores in participants receiving d-AMPH (d-amphetamine) compared to PBO.

Hypothesis 5: ER-MAS will decrease impulsivity as measured by several self-report (Barratts Impulsivity Scale) and behavioral measures (Card Sort, IMT (immediate memory task), DMT (delayed memory task), BART) compared to PBO.

This 14-week, three arm (two medication doses versus PBO), prospective, parallel groups, randomized PBO-controlled trial with a lead-in as well as medication run-up and run down weeks, will provide clear data on efficacy and safety for definitive Phase III trials, which if successful will lead to improved treatment for A-ADHD/S-SUD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00553319
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 2/Phase 3
Start date December 2007
Completion date July 2013
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 NCT00842517 - Long Term Maintenance of Drug Abstinence Phase 1
Completed NCT00167245 - Topiramate for Alcohol and Cocaine Dependence Phase 2
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