Drug AddictionNCT01722006
Drug Effects on Preference and Reward
An observational study of Drug Addiction, run by University of Chicago at 1 site in United States.
Trial summary
Classical conditioning is widely used to study motivational properties of addictive drugs in animals, but has rarely been used in humans. Here, we are establishing a procedure suitable for studying the neurobiology and individual determinants of classical conditioning in humans. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Addiction
- What is being tested?
- Pairing condition
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy adults
Who may be able to join
- 18-35, good healthy, normal weight, high school education, normal electrocardiogram, no psychiatric disorders,
Who cannot join
- current medications, night shift work, abnormal electrocardiogram, medical problems
Trial locations and contacts
1 site in 1 country.
About this study
Classical conditioning is widely used to study motivational properties of addictive drugs in animals, but has rarely been used in humans. Here, we are establishing a procedure suitable for studying the neurobiology and individual determinants of classical conditioning in humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine or placebo in the presence of distinctive environmental cues under paired or unpaired conditions. During each session, subjects perform tasks known to activate the ventral striatum in fMRI studies. The tasks are performed in the presence of a distinctive context, consisting of a screen background image of a beach or of mountains, accompanied by corresponding sounds. Separate groups of subjects carry out the tasks under high or low reward conditions. Within each of the two reward conditions, one group (paired), receives methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts, while the other (unpaired) receives drug or placebo unrelated to context. A fifth group (paired) perform the tasks with contextual cues but in the absence of monetary incentives. Before and after conditioning, participants carry out a series of forced choice tasks, and change of preference over time was analyzed.
Read the detailed description
Subjects are assigned to one of 5 groups: Paired, high reward (PairHi; n=24); Paired, low reward (PairLo; n=24); Paired no reward (PairNone; n=23); Unpaired, high reward (UnpHi; n=7); and Unpaired, low-reward (UnpLo; n=9). Each participant attends an orientation session, followed by four 4h conditioning sessions separated by at least 48h, and a 2h test session. During the initial orientation session, subjects practice the computer tasks together with the environmental stimuli to be paired during the conditioning sessions, and carry out a series of choices for the tasks and images (see below). All subjects receive methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions. Subjects differ in whether environmental stimuli are consistently paired with the drug administration. The three paired groups consistently receive drug and placebo in combination with one of the two sets of visual and auditory background stimuli (see below). The two unpaired groups receive each treatment in combination with one of the stimuli sets on one session, and the other on the other.
During all four conditioning sessions, subjects perform a series of computer tasks. Depending on group assignment, subjects are able to earn high ( PairHi, UnpHi) or low monetary reward ( PairLo, UnpLo), but this is not contingent on subjects' performance. Each run for each game begins with a credit to prevent a negative outcome early in the run. The PairNone group play the same games without monetary reward. The order of the three games and the background images used are randomized across subjects, but remain constant within subjects.
Tasks are presented in the presence of the two distinctive compound stimuli consisting of a background screen visible behind the task presentation and accompanied by a corresponding sound. One set of stimuli depicts a summer beach view accompanied by the sound of ocean waves. The other depicts summer alpine scenery accompanied by birdsong.
The primary outcome measure is the change in preference ratings for the study stimuli, from before to after conditioning. This is a behavioral study, designed to develop a novel procedure for future imaging studies.
- Conditions
- Drug Addiction
- Being tested
- Pairing condition
- Keywords
- methamphetamine, subjective, conditioning, preference
- 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.
Pairing conditionBehavioural
Pairing conditionBehavioural
Also called Paired, unpaired, Low, high or no reward
20 mg methamphetamine or placebo on four 4-hour laboratory sessions
| Study group | Role | What they receive |
|---|---|---|
| Pairing group | Paired, high reward, oral methamphetamine (20 mg) vs placebo Paired, low reward, oral methamphetamine (20 mg) vs placebo Paired, no reward, oral methamphetamine (20 mg) vs placebo Unpaired, oral methamphetamine (20 mg) vs placebo Receives: Behavioral: Pairing condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference for paired stimulus
Subjects rate their preference for several pairs of stimuli before and after conditioning pairings. The stimuli are presented on a computer screen in the pre and post preference tests, and the change in preference after the conditioning trials is the primary outcome measure.
Measured: 2-3 weeks
Secondary outcomes (1)
Subjective responses to methamphetamine
Subjects complete standardized mood questionnaires after receiving methamphetamine or placebo on each of the four conditioning trials. Blood pressure and heart rate are also measured at these times.
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startDec 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- More trials run by University of 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
- Observational
- Observational model
- Case only
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Harriet de Wit, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722006
- Sponsor's protocol ID
- 10-618A
- Other IDs
- R01DA002812, HHSN275201100328P
- Status last verified
- Nov 2012
- First submitted
- 29 Oct 2012
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Effects on Preference and Reward
- ClinicalTrials.gov ID
- NCT01722006
- Acronym / sponsor ID
- 10-618A
- Conditions
- Drug Addiction
- Keywords
- methamphetamine, subjective, conditioning, preference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Classical conditioning is widely used to study motivational properties of addictive drugs in animals, but has rarely been used in humans. Here, we are establishing a procedure suitable for studying the neurobiology and individual determinants of classical conditioning in humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine or placebo in the presence of distinctive environmental cues under paired or unpaired conditions. During each session, subjects perform tasks known to activate the ventral striatum in fMRI studies. The tasks are performed in the presence of a distinctive context, consisting of a screen background image of a beach or of mountains, accompanied by corresponding sounds. Separate groups of subjects carry out the tasks under high or low reward conditions. Within each of the two reward conditions, one group (paired), receives methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts, while the other (unpaired) receives drug or placebo unrelated to context. A fifth group (paired) perform the tasks with contextual cues but in the absence of monetary incentives. Before and after conditioning, participants carry out a series of forced choice tasks, and change of preference over time was analyzed.
Detailed description
Subjects are assigned to one of 5 groups: Paired, high reward (PairHi; n=24); Paired, low reward (PairLo; n=24); Paired no reward (PairNone; n=23); Unpaired, high reward (UnpHi; n=7); and Unpaired, low-reward (UnpLo; n=9). Each participant attends an orientation session, followed by four 4h conditioning sessions separated by at least 48h, and a 2h test session. During the initial orientation session, subjects practice the computer tasks together with the environmental stimuli to be paired during the conditioning sessions, and carry out a series of choices for the tasks and images (see below). All subjects receive methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions. Subjects differ in whether environmental stimuli are consistently paired with the drug administration. The three paired groups consistently receive drug and placebo in combination with one of the two sets of visual and auditory background stimuli (see below). The two unpaired groups receive each treatment in combination with one of the stimuli sets on one session, and the other on the other.
During all four conditioning sessions, subjects perform a series of computer tasks. Depending on group assignment, subjects are able to earn high ( PairHi, UnpHi) or low monetary reward ( PairLo, UnpLo), but this is not contingent on subjects' performance. Each run for each game begins with a credit to prevent a negative outcome early in the run. The PairNone group play the same games without monetary reward. The order of the three games and the background images used are randomized across subjects, but remain constant within subjects.
Tasks are presented in the presence of the two distinctive compound stimuli consisting of a background screen visible behind the task presentation and accompanied by a corresponding sound. One set of stimuli depicts a summer beach view accompanied by the sound of ocean waves. The other depicts summer alpine scenery accompanied by birdsong.
The primary outcome measure is the change in preference ratings for the study stimuli, from before to after conditioning. This is a behavioral study, designed to develop a novel procedure for future imaging studies.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pairing group | – | Behavioral: Pairing conditionPaired, high reward, oral methamphetamine (20 mg) vs placebo Paired, low reward, oral methamphetamine (20 mg) vs placebo Paired, no reward, oral methamphetamine (20 mg) vs placebo Unpaired, oral methamphetamine (20 mg) vs placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy adults
Key inclusion criteria (1 listed)
- 18-35, good healthy, normal weight, high school education, normal electrocardiogram, no psychiatric disorders,
Key exclusion criteria (1 listed)
- current medications, night shift work, abnormal electrocardiogram, medical problems
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 |
|---|---|---|
| Pairing condition | Behavioural | Pairing group |
| Pairing conditionAlso: Paired, unpaired, Low, high or no reward20 mg methamphetamine or placebo on four 4-hour laboratory sessions | Behavioural | Pairing group |
Primary outcome
Preference for paired stimulus
Time frame: 2-3 weeks
Subjects rate their preference for several pairs of stimuli before and after conditioning pairings. The stimuli are presented on a computer screen in the pre and post preference tests, and the change in preference after the conditioning trials is the primary outcome measure.
1 secondary outcome
Subjective responses to methamphetamine
Time frame: 2-3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
Harriet de Wit, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Addiction, run by University of 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 1 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 5 Sep 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preference for paired stimulus (time frame: 2-3 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 5 Sep 2013.