TerminatedPhase 2/3

Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

Stopped: No funding for this project

United States19 participantsStarted 2021-01-21

Plain-language summary

To determine if baclofen will enhance buprenorphine analgesia for acute pain in healthy volunteers.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years or older * general good health * English speaking Exclusion Criteria: * Pregnant or nursing * Opioid use disorder or any substance use disorder other than nicotine * Prescribed agonist treatment for opioid dependence or prescribed opioids for a medical condition * Prescribed naltrexone * Known sensitivity to buprenorphine, naloxone, or baclofen * Acute or chronic pain condition * Trouble breathing or a pulmonary condition * Prescribed benzodiazepines or daily use of benzodiazepines * Positive drug screen (positive cannabis result allowed) * Cognitive impairment or psychiatric disorder requiring treatment * Uncontrolled hypertension

What they're measuring

Pain Threshold

Timeframe: Baseline

Pain Threshold

Timeframe: 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit

Pain Tolerance

Timeframe: Baseline

Pain Tolerance

Timeframe: 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit

Temporal Summation of Pain

Timeframe: Baseline

Temporal Summation of Pain

Timeframe: 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit

Conditioned Pain Modulation

Timeframe: Baseline

Conditioned Pain Modulation

Timeframe: 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit

Trial details

NCT IDNCT04251819

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-15

Results submitted2025-06-20

View on ClinicalTrials.gov More Acute Pain trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pain Threshold

Timeframe: Baseline

Pain Threshold

Timeframe: 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit

Pain Tolerance

Timeframe: Baseline

Pain Tolerance

Timeframe: 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit

Temporal Summation of Pain

Timeframe: Baseline

Temporal Summation of Pain

Timeframe: 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit

Conditioned Pain Modulation

Timeframe: Baseline

Conditioned Pain Modulation

Timeframe: 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit