Substance-Related DisordersPhase 4NCT03075501
Interactions Between Drug Effects and Environments II
A Phase 4 study testing Paired and Stimulant or sedative in people with Substance-Related Disorders, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of the study is to determine how associations between drugs and the places where they are experienced influence drug seeking, mood and acute drug responses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Paired and Stimulant or sedative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jul 2020
- Phase
- Phase 4
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- past use of stimulants
- bmi 19-26
- hormonal birth control for women
Who cannot join
- current or recent (Past year) history of major axis I disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Drug Contextual Conditioning With in Humans: Causes and Consequences
The purpose of the study is to determine how associations between drugs and the places where they are experienced influence drug seeking, mood and acute drug responses.
Read the detailed description
Learned associations between drug effects and the people, places, and paraphernalia (cues) linked with drug experiences are a major barrier to the treatment of drug addiction. These links are remarkably persistent and can cause relapse to drug taking even after long periods of abstinence. They are also key features in some of the foremost theories of addiction, yet there is little clinical evidence of how these associations are formed and how they come to profoundly control behavior. The long-term goal of this research is to understand how drug cues become powerfully linked with drug experiences and their influence on mood and behavior. In the proposed project, the investigators will use a de novo conditioning paradigm to examine the influence of drug contexts on drug seeking, mood and acute drug responses. The hypothesis is that drug-paired contexts gain motivational salience, induce approach, and alter acute subjective responses to the drug.This knowledge will lead to novel treatment strategies to counteract the effects of drug cues on mood and behavior, and also to prevent relapse.
- Conditions
- Substance-Related Disorders
- Being tested
- Paired, Stimulant or sedative, Placebo
- Keywords
- drug cues
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PairedBehavioural
Also called Conditioned place preference
Drug conditioning is assessed by pairing drug administration with a given context.
Stimulant or sedativeDrug
CS+ for paired, CS0 for unpaired
PlaceboDrug
CS- for paired, CS0 for unpaired
| Study group | Role | What they receive |
|---|---|---|
| Paired | Active comparator | Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room. Receives: Behavioral: Paired; Drug: Stimulant or sedative; Drug: Placebo |
| Unpaired | Other | Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. Receives: Drug: Stimulant or sedative; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time Spent in Drug-paired Room
The amount of time spent in the two testing rooms is assessed during a 10min exploration test conducted at the orientation session (pre-test) and again at the testing session (post-test). Between the pre- and post-tests, participants complete 4 drug administration sessions; 2 with 20mg MA, 2 with 0mg MA. The Paired Group always receives 20mg MA in the room they spent the least time in at pre-test, and 0mg MA in the other room. The Unpaired Group receives 20mg MA and 0mg MA once in each room. The research question is whether the Paired Group spends significantly more time in the room paired with 20mg MA in comparison to the Unpaired Group. Thus, the outcome measure is the difference in time spent in the room paired with drug administration (i.e. the room that they spent the least time in at pre-test) between pre- and post-tests (i.e., post-test time spent - pre-test time spent) which is compared between the groups. NOTE: Time spent is NOT obtained during drug administration sessions.
Measured: Measured through study completion (maximum 5 weeks).
Secondary outcomes (1)
Subjective Drug Effects
Self-reported drug effects are measured using standardized questionnaires 30min before capsule administration (baseline) and at 30min intervals after capsule administration for 4h during each drug administration session. The peak change from baseline is calculated for each session and averaged across drug and placebo sessions. A net difference is calculated by subtracting the mean peak change from baseline during placebo sessions from the mean peak change from baseline during drug (20mg MA) sessions.
Outcome measure: Subjective stimulation (i.e., feeling alert, aroused, energetic) is measured using the Amphetamine scale of the Addiction Research Center Inventory. Scores range from 0-11 with greater scores indicating greater drug effects.
Measured: Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startNov 2015
- Primary completionJul 2020
- Study completionJul 2020
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 Substance-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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Emma Childs, University of Illinois Chicago
- Investigators
- Emma Childs, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075501
- Sponsor's protocol ID
- 2015-0075
- Other IDs
- R21DA033488-01A1
- Status last verified
- Apr 2021
- First submitted
- 18 May 2016
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Contextual Conditioning With in Humans: Causes and Consequences
- ClinicalTrials.gov ID
- NCT03075501
- Acronym / sponsor ID
- 2015-0075
- Conditions
- Substance-Related Disorders
- Keywords
- drug cues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 19 May 2021
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 the study is to determine how associations between drugs and the places where they are experienced influence drug seeking, mood and acute drug responses.
Detailed description
Learned associations between drug effects and the people, places, and paraphernalia (cues) linked with drug experiences are a major barrier to the treatment of drug addiction. These links are remarkably persistent and can cause relapse to drug taking even after long periods of abstinence. They are also key features in some of the foremost theories of addiction, yet there is little clinical evidence of how these associations are formed and how they come to profoundly control behavior. The long-term goal of this research is to understand how drug cues become powerfully linked with drug experiences and their influence on mood and behavior. In the proposed project, the investigators will use a de novo conditioning paradigm to examine the influence of drug contexts on drug seeking, mood and acute drug responses. The hypothesis is that drug-paired contexts gain motivational salience, induce approach, and alter acute subjective responses to the drug.This knowledge will lead to novel treatment strategies to counteract the effects of drug cues on mood and behavior, and also to prevent relapse.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paired | Active comparator | Behavioral: Paired, Drug: Stimulant or sedative, Drug: PlaceboIndividuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room. |
| Unpaired | Other | Drug: Stimulant or sedative, Drug: PlaceboIndividuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- past use of stimulants
- bmi 19-26
- hormonal birth control for women
Key exclusion criteria (1 listed)
- current or recent (Past year) history of major axis I disorder
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 |
|---|---|---|
| PairedAlso: Conditioned place preferenceDrug conditioning is assessed by pairing drug administration with a given context. | Behavioural | Paired |
| Stimulant or sedativeCS+ for paired, CS0 for unpaired | Drug | Paired, Unpaired |
| PlaceboCS- for paired, CS0 for unpaired | Drug | Paired, Unpaired |
Primary outcome
Change in Time Spent in Drug-paired Room
Time frame: Measured through study completion (maximum 5 weeks).
The amount of time spent in the two testing rooms is assessed during a 10min exploration test conducted at the orientation session (pre-test) and again at the testing session (post-test). Between the pre- and post-tests, participants complete 4 drug administration sessions; 2 with 20mg MA, 2 with 0mg MA. The Paired Group always receives 20mg MA in the room they spent the least time in at pre-test, and 0mg MA in the other room. The Unpaired Group receives 20mg MA and 0mg MA once in each room. The research question is whether the Paired Group spends significantly more time in the room paired with 20mg MA in comparison to the Unpaired Group. Thus, the outcome measure is the difference in time spent in the room paired with drug administration (i.e. the room that they spent the least time in at pre-test) between pre- and post-tests (i.e., post-test time spent - pre-test time spent) which is compared between the groups. NOTE: Time spent is NOT obtained during drug administration sessions.
1 secondary outcome
Subjective Drug Effects
Time frame: Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Emma Childs, PhD 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 4 study testing Paired and Stimulant or sedative in people with Substance-Related Disorders, 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 3 inclusion and 1 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 19 May 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 May 2021). 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?
Change in Time Spent in Drug-paired Room (time frame: Measured through study completion (maximum 5 weeks).). 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 19 May 2021.