Methamphetamine AbuseEarly Phase 1NCT01967381
Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse
A Early Phase 1 study testing Methamphetamine (Desoxyn®) in people with Methamphetamine Abuse and Methamphetamine Dependence, run by University of Kentucky at 1 site in United States.
Trial summary
The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Abuse, Methamphetamine Dependence
- What is being tested?
- Methamphetamine (Desoxyn®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2018
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Lifetime methamphetamine use
Who cannot join
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to methamphetamine (Desoxyn®), oxazepam (Serax®) or naltrexone (Revia®)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.
- Conditions
- Methamphetamine Abuse, Methamphetamine Dependence
- Being tested
- Methamphetamine (Desoxyn®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methamphetamine (Desoxyn®)Drug
The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Subjects will be maintained on oral placebo. Receives: Drug: Methamphetamine (Desoxyn®) |
| Arm 2 | Experimental | Subjects will be maintained on oral oxazepam (Serax®). Receives: Drug: Methamphetamine (Desoxyn®) |
| Arm 3 | Experimental | Subjects will be maintained on oral naltrexone (Revia®). Receives: Drug: Methamphetamine (Desoxyn®) |
| Arm 4 | Experimental | Subjects will be maintained on oral naltrexone (Revia®) and oral oxazepam (Serax®). Receives: Drug: Methamphetamine (Desoxyn®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Effects
The reinforcing effects of methamphetamine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, oxazepam (Serax®), naltrexone (Revia®), and oxazepam and naltrexone combined.
Measured: After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance
Secondary outcomes (2)
Subjective Effects
Subjects will complete subjective effects measures during six sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood.
Measured: 12 sessions over approximately 4 week inpatient admissions
Physiological and Side Effects
Physiological and side effects measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include heart rate and blood pressure. Side Effects questions will query subjects about common effects of centrally active medications.
Measured: Daily over approximately 4 week inpatient admissions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Craig Rush, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967381
- Sponsor's protocol ID
- R01DA033394
- Status last verified
- Sep 2018
- First submitted
- 15 Oct 2013
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse
- ClinicalTrials.gov ID
- NCT01967381
- Acronym / sponsor ID
- R01DA033394
- Conditions
- Methamphetamine Abuse, Methamphetamine Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 22 Oct 2013 (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.
The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: Methamphetamine (Desoxyn®)Subjects will be maintained on oral placebo. |
| Arm 2 | Experimental | Drug: Methamphetamine (Desoxyn®)Subjects will be maintained on oral oxazepam (Serax®). |
| Arm 3 | Experimental | Drug: Methamphetamine (Desoxyn®)Subjects will be maintained on oral naltrexone (Revia®). |
| Arm 4 | Experimental | Drug: Methamphetamine (Desoxyn®)Subjects will be maintained on oral naltrexone (Revia®) and oral oxazepam (Serax®). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Lifetime methamphetamine use
Key exclusion criteria (5 listed)
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to methamphetamine (Desoxyn®), oxazepam (Serax®) or naltrexone (Revia®)
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 |
|---|---|---|
| Methamphetamine (Desoxyn®)The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance. | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Reinforcing Effects
Time frame: After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance
The reinforcing effects of methamphetamine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, oxazepam (Serax®), naltrexone (Revia®), and oxazepam and naltrexone combined.
2 secondary outcomes
Subjective Effects
Time frame: 12 sessions over approximately 4 week inpatient admissions
Physiological and Side Effects
Time frame: Daily over approximately 4 week inpatient admissions
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 14 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methamphetamine (Desoxyn®) in people with Methamphetamine Abuse and Methamphetamine Dependence, run by University of Kentucky 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 5 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 14 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reinforcing Effects (time frame: After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance). 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 14 Sep 2018.