Targeting Anhedonia in Cocaine Use Disorder

NCT ID: NCT02773212

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2022-04-04

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.

Detailed Description

Recent research suggests that anhedonia is a key neurobehavioral dysfunction in Cocaine Use Disorder (CUD) that contributes to treatment outcomes. Anhedonia, defined here as lack of interest or pleasure in non-drug rewards, is frequently found in CUD and is related to neural deficits, such as low striatal dopamine and deficient activation to non-drug rewards in mesocortical circuits. Interestingly, not all individuals in CUD have these deficits. Preliminary data suggests that the presence of self-reported anhedonia predicts worse outcome in contingency management (CM) treatment of CUD. Moreover, low baseline dopamine predicts failure to attain abstinence in CM while medications that enhance DA increase CM success rates and responsiveness to rewards.

This study specifically aims to test the contribution of anhedonia to overall CUD severity, the relationship of anhedonia to outcomes in CM treatment, and the mediating role of anhedonia in medication enhancement of CM in CUD. To accomplish these aims, individuals with CUD will be enrolled and will undergo 4 weeks of intensive CM treatment, either with or without treatment with the dopaminergic drug, d-amphetamine. A medication only group will be included to solely measure the effects of d-amphetamine. Anhedonia will be assessed using multi-modal subjective, psychophysiological and behavioral measures of reward functioning at baseline, and each week of treatment. Functional magnetic resonance imaging (fMRI) measures of reward functioning will also be taken at baseline and week 4 in a subset of participants (n = 24)

Conditions

Cocaine-Related Disorders; Anhedonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

d-Amphetamine and Contingency Management

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.

Group Type: EXPERIMENTAL

d-amphetamine

Intervention Type: 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.

Contingency management

Intervention Type: BEHAVIORAL

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

d-Amphetamine alone

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.

Group Type: ACTIVE_COMPARATOR

d-amphetamine

Intervention Type: 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.

Placebo and Contingency Management

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

Group Type: ACTIVE_COMPARATOR

Contingency management

Intervention Type: BEHAVIORAL

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

Placebo (for d-amphetamine)

Intervention Type: DRUG

60 mg of riboflavin and cornstarch as needed.

Interventions

d-amphetamine

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.

Intervention Type: DRUG

Contingency management

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

Intervention Type: BEHAVIORAL

Placebo (for d-amphetamine)

60 mg of riboflavin and cornstarch as needed.

Intervention Type: DRUG

Other Intervention Names

sustained release d-amphetamine; dexedrine

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Margaret.C.Wardle

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret C Wardle, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-0827

Identifier Type: -

Identifier Source: org_study_id