Cocaine-Related DisordersPhase 2NCT02773212
Targeting Anhedonia in Cocaine Use Disorder
A Phase 2 study testing d-amphetamine and Contingency management in people with Cocaine-Related Disorders and Anhedonia, run by University of Illinois Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine-Related Disorders, Anhedonia
- What is being tested?
- d-amphetamine and Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 4 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 15Show fewer
- 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
- Additional Exclusion Criteria for the functional magnetic resonance (fMRI) Sub-Study (in addition to all listed criteria above for the Main Treatment Study):
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60607
About this study
Official title: Targeting Anhedonia in Cocaine Use Disorder - Treatment Study
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.
Read the 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
- Being tested
- d-amphetamine, Contingency management, Placebo (for d-amphetamine)
- Medical subject headings
- Cocaine-Related Disorders, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-amphetamineDrug
Also called sustained release d-amphetamine, dexedrine
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 managementBehavioural
Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
Placebo (for d-amphetamine)Drug
60 mg of riboflavin and cornstarch as needed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Contingency management; Drug: Placebo (for d-amphetamine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At end of active treatment (Treatment week 4)
Secondary outcomes (1)
Cocaine Negative Urine Samples
Subjects will complete a urine drug screen each visit (3x weekly). The Treatment Effectiveness Score is defined as the total number of cocaine negative urines across the 4 weeks of treatment (possible total of 12).
Measured: At end of active treatment (Treatment week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start1 Feb 2017
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret.C.Wardle, University of Illinois Chicago
- Investigators
- Margaret C Wardle, Ph.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773212
- Sponsor's protocol ID
- 2018-0827
- Status last verified
- Aug 2024
- First submitted
- 6 May 2016
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the individual participant data collected in the trial will be made available after deidentification via signed data use agreement. The study protocol and data analysis plan will also be made available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Anhedonia in Cocaine Use Disorder - Treatment Study
- ClinicalTrials.gov ID
- NCT02773212
- Acronym / sponsor ID
- 2018-0827
- Conditions
- Cocaine-Related Disorders, Anhedonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| d-Amphetamine and Contingency Management | Experimental | Drug: d-amphetamine, Behavioral: Contingency managementParticipants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder. |
| d-Amphetamine alone | Active comparator | Drug: d-amphetamineParticipants 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. |
| Placebo and Contingency Management | Active comparator | Behavioral: Contingency management, Drug: Placebo (for d-amphetamine)Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| d-amphetamineAlso: sustained release d-amphetamine, dexedrineParticipants 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. | Drug | d-Amphetamine alone, d-Amphetamine and Contingency Management |
| Contingency managementContingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence. | Behavioural | Placebo and Contingency Management, d-Amphetamine and Contingency Management |
| Placebo (for d-amphetamine)60 mg of riboflavin and cornstarch as needed. | Drug | Placebo and Contingency Management |
Primary outcome
Number of Participants Who Were Cocaine Abstinent as Assessed by Urine Screening (Measure of Treatment Efficacy)
Time frame: At end of active treatment (Treatment week 4)
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.
1 secondary outcome
Cocaine Negative Urine Samples
Time frame: At end of active treatment (Treatment week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All the individual participant data collected in the trial will be made available after deidentification via signed data use agreement. The study protocol and data analysis plan will also be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret C Wardle, Ph.D. principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing d-amphetamine and Contingency management in people with Cocaine-Related Disorders and Anhedonia, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Were Cocaine Abstinent as Assessed by Urine Screening (Measure of Treatment Efficacy) (time frame: At end of active treatment (Treatment week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.