Targeting Anhedonia in Cocaine Use Disorder

NCT02773212 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2018-0827
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine anhedonia as a potential moderator of treatment outcomes for Cocaine Use Disorder (CUD). Specifically, this study will investigate how anhedonia affects outcomes in contingency management (CM) treatment for CUD and whether anhedonia mediates the effects of adjunctive treatment with a dopaminergic (DAergic) drug, d-amphetamine, on outcomes in CM for CUD, as well as investigate the contribution of anhedonia to overall CUD severity.

Conditions

Cocaine-Related Disorders; Anhedonia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were Cocaine Abstinent as Assessed by Urine Screening (Measure of Treatment Efficacy)

  Subjects will complete a urine drug screen each visit. Achievement of cocaine abstinence will be defined as two consecutive weeks of cocaine-negative urine samples.

  At end of active treatment (Treatment week 4)

Secondary Outcomes (1)

• Cocaine Negative Urine Samples

  At end of active treatment (Treatment week 4)

Study Arms (3)

d-Amphetamine and Contingency Management

EXPERIMENTAL

Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.

Drug: d-amphetamine; Behavioral: Contingency management

d-Amphetamine alone

ACTIVE COMPARATOR

Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine but will not receive contingency management treatment for cocaine use disorder.

Drug: d-amphetamine

Placebo and Contingency Management

ACTIVE COMPARATOR

Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.

Behavioral: Contingency management; Drug: Placebo (for d-amphetamine)

Interventions

d-amphetamine DRUG

Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.

Also known as: sustained release d-amphetamine, dexedrine

d-Amphetamine alone; d-Amphetamine and Contingency Management

Contingency management BEHAVIORAL

Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.

Placebo and Contingency Management; d-Amphetamine and Contingency Management

Placebo (for d-amphetamine) DRUG

60 mg of riboflavin and cornstarch as needed.

Placebo and Contingency Management

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• be between 18 and 60 years of age
• meet Diagnostic and Statistical Manual V (DSM-5) criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
• have at least 1 cocaine positive urine sample during the baseline screening period
• be in acceptable health on the basis of interview, medical history and physical exam, per the judgment of our study physician
• be able to understand the consent form and provide written informed consent
• be able to provide the names of at least 2 persons who can generally locate their whereabouts.
• if female, agree to use an acceptable method of birth control during study (surgical sterilization, approved hormonal contraceptives, barrier methods with spermicide, or intrauterine device).

You may not qualify if:

• current DSM-5 diagnosis for substance use disorder of least moderate severity (≥ 4 symptoms), other than cocaine, nicotine, marijuana, or alcohol
• Physical dependence on alcohol requiring medically supervised detoxification, in the judgment of the study physician
• current amphetamine use (by self-report in past 30 days or positive urine drug screen), more than 50 lifetime uses of amphetamine, or history of DSM-5 Amphetamine Use Disorder
• a current DSM-5 axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
• significant current suicidal or homicidal ideation
• medical conditions contraindicating d-amphetamine (e.g., significant cardiovascular disease, liver or kidney disease, seizure disorder, hypotension or hypertension)
• taking medications known to have effects on the central nervous system or that could cause significant drug interactions with d-amphetamine (e.g., clonidine, prazosin)
• having conditions of probation or parole requiring reports of drug use to officers of the court
• impending incarceration
• pregnant or nursing for female patients
• inability to read, write, or speak English
• body mass index (BMI) \>30, as this may be incompatible with the magnetic resonance scanner gantry
• any retained metals in the body, including implants and metallic substances (e.g. aneurysm clips, retained metal particles in metal workers, magnetic dental implants, ferromagnetic ocular implants, iron-based facial tattoos), as this may cause adverse effects to participants and interfere with data collection in the MR magnetic field
• inability to tolerate small, enclosed spaces (such as the magnetic resonance scanner bore)

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Anhedonia

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

1. Due to recruitment issues during COVID-19 pandemic trial was terminated early (57 out of a planned 80 participants enrolled) 2. Due to complications from PI move and COVID, functional magnetic resonance imaging sub-study was never initiated. 3. During COVID-19 pandemic zygomatic muscle readings were not collected, as this would have required participants to remove masks

Results Point of Contact

• Title: Dr. Margaret Wardle
• Organization: University of Illinois at Chicago

mwardle@uic.edu

(312)413-5564

Study Officials

• Margaret C Wardle, Ph.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 16, 2016
• Study Start: February 1, 2017
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available beginning immediately and for 3 years following the last publication from this data
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal, and to achieve the aims in the approved proposal. Proposals should be directed to mwardle@uic.edu. To gain access, data requestors will need to sign a data access agreement that will provide that the data be used solely for research and that no individuals will be identified in any manner, that data will be secured by appropriate electronic safeguards, and that once data analysis is complete, the data will be returned or destroyed. After the agreement is signed the PI will provide the necessary data to achieve proposal aims via an agreed-upon electronic method (e.g. Box Drive, university e-mail etc.)

Locations

US (1)